PRIME-CKD

Less pills, better pills

Personalized Drug Response:
Implementation and Evaluation in CKD (Chronic Kidney Disease)

About Prime-CKD

Chronic Kidney Disease (CKD) is one of the major causes of death in high income countries and its prevalence is growing rapidly. New therapies for the treatment of CKD have shown clear efficacy at a population level. Yet, individual patients respond differently with many patients showing suboptimal efficacy. This indicates that a ‘one size fits all’ approach is no longer sustainable. Currently there are no validated biomarkers (i.e. signal-substances that can be measured in blood or urine) in patients with CKD that aid in guiding optimal therapy for individual patients. Furthermore, there remains a large gap between biomarker research and actual implementation of biomarker based care in daily clinical practice.

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Our work packages

Work Package 1

Analytical and clinical validation of the pharmacodynamic response biomarkers in CKD patients. 

Work Package 2

Clinical validation of the pharmacodynamic response biomarkers in completed clinical trials.

Work Package 3

Clinical validation of the pharmacodynamic response biomarkers in a prospective  novel clinical trial. 

Work Package 4

Optimization of biomarker qualification procedures with regulatory agencies. 

Work Package 5

Clinical practice implementation. 

Work Package 6

Networking, communication and exploitation.

Work Package 7

Coordination, project, and data management

Our partners

UKE

REGION H

UNIVERSITY OF LEICESTER

INCLIVA

Dutch Kidney Foundation

CLV

UNIBO

LUNDS UNIVERSITET

UKER

HESS

UMCG

Renalytix

CBG

MICHIGAN MEDICINE

UKE

The III. Department of Medicine at the University Medical Center Hamburg-Eppendorf is dedicated to the care of patients and to experimental and clinical kidney research with a number of national and international collaborations and internationally leading research programs aiming to identify mechanisms and new treatment options for various human kidney diseases. As part of PRIME CKD, the UKE is leading an international study validating analytical aspects relevant for the clinical measurement of biomarker-based tests to predict the response of patients with CKD to existing drugs.

People involved in Prime-CKD:

Tobias B Huber (Prof., MD)

Chair of the Center of Internal Medicine, UKE, Hamburg, Germany
Director of the III. Department of Medicine, UKE, Hamburg, Germany
Project Leader WP1/ Clinical Head

Maja Lindenmeyer (PD, PhD)

Laboratory Head/Head OF Biobank at the III. Department of Medicine, UKE, Hamburg, Germany
Deputy Study Coordinator UVALID Study

Elisabeth Meister (MD)

Clinician scientist at the III. Department of Medicine, UKE, Hamburg, Germany
Study Coordinator UVALID Study

REGION H

Steno Diabetes Center Copenhagen (SDCC) is specialized in patient care, research, prevention of diabetes, and educating healthcare professionals working with diabetes. SDCC is the largest diabetes clinic in Scandinavia, treating annually more than 11,000 people with diabetes from the Capital Region of Denmark. SDCC aims to offer world-class treatment and contribute to a better life and health quality for people with diabetes, their relatives, and citizens at risk. 

In PRIME-CKD SDCC act as a lead partner in WP3 and as a participating partner in WP1, 4, 6 and 7.

People involved in Prime-CKD:

Peter Rossing, Professor, MD, DMSc, Head of Complications Research SDCC

Clinician researcher in diabetic complications, focusing on complications of the kidney and cardiovascular system, but also diabetic nerve damage and foot ulcers. Involved in several EU projects, and in clinical trials with new treatments that may be promising for preventing and treating diabetic complications.
Responsibilities in PRIME-CKD include, but are not limited to: 
– Sponsor/lead in WP3
– SDCC Principal investigator in WP1 and WP3.

Frederik Persson, Senior Researcher, MD, DMSc

Research in diabetic complications, focusing on diabetic nephropathy.
Responsibilities in PRIME-CKD include, but are not limited to: 
– Co-lead and ethical coordinator in WP3.  

Marte Opseth Rygg, Ph.d. student, MD

Research in diabetic complications, focusing on diabetic nephropathy. 
Responsibilities in PRIME-CKD: sub-investigator in WP1 and WP3.

UNIVERSITY OF LEICESTER

The University of Leicester hosts the Kidney Research Team which is led by Professor Jonathan Barratt. We have extensive laboratory facilities to study kidney disease from the single cell to highly complex models using cutting edge technologies. The John Walls Renal Unit at the University Hospitals of Leicester NHS Trust looks after kidney patients with all forms of kidney disease and has a very active clinical trials unit. The Hospital and University teams work very closely together to ensure that we are able to offer our patients the opportunity to get involved in a large range of research studies, including clinical trials of the newest therapies. 

People involved in Prime-CKD:

Professor Jonathan Barratt & Dr Chee Kay Cheung are clinician scientists who undertake bench to bedside research into the causes and treatment of kidney diseases that affect the fine filters (glomeruli) of the kidneys. They have a major interest in IgA nephropathy, the commonest cause of glomerular disease in the world. This disease mostly affects young adults and commonly causes kidney failure. We have an active clinical trial program running at the John Walls Renal Unit where we treat patients with glomerular disease and a large laboratory facility at the University of Leicester where we study different experimental models of kidney damage. 

INCLIVA

INCLIVA Health Research Institute manages biomedical research carried out by the Hospital Clínico Universitario in Valencia and its Health Department, as well as certain scientific excellence groups from the Faculty of Medicine at the University of Valencia and the Carlos Simon Foundation.

Our team is included in the Research Group on the Study of Cardiometabolic and Renal Risk of INCLIVA.Our Renal Clinical trials Unit has experience in more than 40 studies in patients with chronic kidney disease and dialysis. The team is formed of 4 nephrologist , 1 study nurse/ study coordinator, one data manager and we collaborate with CEU Cardenal Herrera University in the training of new clinical trial staff. In addition, we also carry own and industry trials.

Dr. Gorriz

Dr Gorriz is Head of the Nephrology Department in the Clinic University Hospital, Valencia, Spain. He is alsoAssistant Professor of Nephrology at the Faculty of Medicine, Valencia. He is especially dedicated to the field ofclinical nephrology; research areas include chronic kidney disease, diabetic kidney disease, renal progression.

He is one of the coordinators of The Spanish Study Group for Diabetic Nephropathy (GEENDIAB). He has participated as Principal Investigator in more than 20 clinical trials on diabetic kidney disease and has been a National Leader for the studies BEACON (bardoxolone), CREDENCE (canagliflozin), DAPA CKD (dapagliflozin) and FLOW (semaglutide in patients with CKD).

Dr Gorriz is skilled in medical informatics and has used large databases and web technology to coordinate severalmulticentre studies. Dr Gorriz was the Secretary of the Spanish Society of Nephrology from 2008–2014 and is currently President of The Valencian Society of Nephrology.

Lorena Gandía

Study Coordinator / Staff Nurse

Dr. Moncho

Senior associate resident. Sub-Investigator

Dutch Kidney Foundation

The Dutch Kidney Foundation is a health charity, founded in 1968. Our mission is to inspire and stimulate people to join us in our efforts towards a world without kidney disease and a better future for kidney patients.

We support scientific research, advocate kidney health for the general public and invest in patient education and social participation for kidney patients.

 In the PRIME-CKD project the Dutch Kidney Foundation is responsible for networking, communication and exploitation of results through a stakeholder network that assists in the translation of research findings and implementation in clinical practice. 

People involved in Prime-CKD:

Dr. Stijn Gremmen is Work Package Leader for WP6 in the PRIME-CKD consortium and as such involved in networking and communication of results.

Stijn is working as Program Manager at the Dutch Kidney Foundation and involved in funding of scientific research and development projects. Previously, he has worked on complex chemistry problems in industrial drug discovery projects at several contract research organizations (2004 – 2021). He holds a PhD in bioorganic chemistry (University of Amsterdam, 2002). 

CLV

The CLV unit is involved in WP3 (prospective validation by RCT of the farmacodynamic response by biomarkers) and WP6 (Networking, communication, and exploitation).  Activity of this Nephrology Unit focuses on conservative therapy of CKD. Major mission is to delay ESKD by multifactorial therapy, including nutritional intervention and multi-drug approach.  Research includes observational and interventional studies, and meta-analyses. The Unit leads several national studies in Nephrology and has been involved in several international trials.  In particular, Investigators are recognized worldwide for the studies on the prognostic role of 24h blood pressure control in nondialysis CKD.

People involved in Prime-CKD:

Luca De Nicola is Full Professor in Nephrology and Director of Nephrology Unit and Postgraduate School of Nephrology at University of Campania, Naples, Italy, since 2019. His clinical and research activity is mainly dedicated to management of cardiorenal complications in non-dialysis CKD patients. He is author of almost 300 papers published on peer-reviewed internationa journals (H index 47), and he is/has been national leader of several RCTs on nephroprotection in CKD.

Roberto Minutolo is Associate Professor in Nephrology at University of Campania, Naples, Italy, since 2001. His clinical and research activity is mainly dedicated to management of complications in non-dialysis CKD patients. He is responsible for the outpatient clinic activities at Nephrology Division of University of Campania. He is author of more than 200 papers peer-reviewed published on main nephrology journals (H index 45) and he is/has been Member of the Editorial Boards for several journals.

UNIBO

Alma Mater Studiorum University of Bologna (UNIBO) and IRCCS Azienda Ospedaliero-Universitaria of Bologna are partecipating to the project PRIME-CKD. These entities will be involved in WP1, WP3, WP5, WP6, WP7. Thus, UNIBO and IRCCS will contribute to patients recruitment for the UVALID and CKD-bioMatch clinica studies and will be involved into the dissemination of results more specific for WP-5 to WP-7.

People involved in Prime-CKD:

Prof. Gaetano La Manna, MD, PhD
-Professor of Nephrology at University of Bologna
-Director of Nephrology Division at IRCCS Azienda Ospedaliero-Universitaria di Bologna.
-Principal investigator for Alma Mater Studiorum University of Bologna and IRCCS Azienda Ospedaliero-Universitaria of Bologna.

Dr. Michele Provenzano, MD, PhD:
-Junior Assistant Professor
-Researcher at University of Bologna
-Sub-investigator for Alma Mater Studiorum University of Bologna and IRCCS Azienda Ospedaliero-Universitaria of Bologna.

Dr. Giorgia Comai, MD, PhD
-Head of Kidney Transplant Unit at IRCCS Azienda Ospedaliero-Universitaria di Bologna
-Sub-investigator for Alma Mater Studiorum University of Bologna and IRCCS Azienda Ospedaliero-Universitaria of Bologna.

Prof. Irene Capelli, MD, PhD:
-Associate Professor of Nephrology at University of Bologna
-Sub-investigator for Alma Mater Studiorum University of Bologna and IRCCS Azienda Ospedaliero-Universitaria of Bologna.

Dr. Lilio Hu, MD:
-PhD Student in Nephrology
-Sub-investigator for Alma Mater Studiorum University of Bologna and IRCCS Azienda Ospedaliero-Universitaria of Bologna.

LUNDS UNIVERSITET

The participants from Lund University (ULUND) are members of the Lund University Diabetes Centre (LUDC), with ~320 staff members working towards improved diagnosis, prevention and treatment of diabetes. They are located at the Clinical Research Centre of the University, in close connection to the Skåne University Hospital, creating the ideal setting for both basic and clinical research.  

ULUND will participate primarily in WP3 and WP5 activities and to a minor extent in WP6 and WP7. Prof Maria F. Gomez will act as PRIME-CKD vice coordinator, working closely with the coordinator.   

People involved in Prime-CKD:

Maria F. Gomez – Professor of Physiology at the Department of Clinical Sciences, Director of Lund University Diabetes Centre (http://www.ludc.lu.se) and Honorary Skou Professor at the Faculty of Health, Aarhus University, Denmark. After medical school, she completed her Ph.D. in physiology (Lund University; 1998) and post-doctoral studies in Pharmacology (University of Vermont; 2001). She has published ~136 papers and supervised 11 PhD theses, 13 post-docs and >30 students. She’s coordinator of IMI project BEAt-DKD (https://www.beat-dkd.eu/) and vice-coordinator of PRIME-CKD. 

Anders Christensen – Professor of Nephrology at the Department of Clinical Sciences Malmo, Lund University and Head physician of Nephrology at Skåne University Hospital, Malmö, Sweden. After medical school he completed his PhD in clinical chemistry (Lund University 1993). Postdoc at Rockefeller University, MSKCC, New York. His research is focused on GFR-markers, chronic kidney disease, protein research and epidemiology. He has published 100 papers and supervised 7 PhD theses. He is program director for renal care in Sweden. 

Christopher Nilsson – Post doc at the Department of Clinical Sciences Malmo, Lund University. After graduating from medical school at Lund University in 2017, he completed his Ph.D. in internal medicine (Lund University; 2021) focusing on the relationship between ethnicity, blood pressure and renal function. He is currently undergoing his medical residency in Internal medicine and Nephrology at Skåne University Hospital, Malmo. 

Abrar Ahmad – Postdoc at the Department of Clinical Sciences Malmo, Lund University. After graduating from veterinary school at University of Agriculture Faisalabad, Pakistan, he completed his master’s degree in Molecular Medical Biology at Örebro University, Sweden in 2012 and his Ph.D. in medical sciences at Lund University in 2018. His Ph.D. project focused on the identification of genetic biomarkers for the risk prediction of recurrent venous thromboembolism. He has published ~17 papers in the fields of cancer, cardiovascular diseases, and diabetes. 

Hugo Fitipaldi – Postdoctoral Fellow at the Department of Clinical Sciences, Lund University. Hugo Fitipaldi holds a BSc in Physiotherapy from Universidade Federal de Pernambuco (2013) and an MSc in Public Health (MPH) from Lund University (2018). He completed his PhD at the Lund University Diabetes Centre (2023), where he focused on the application of data mining and artificial intelligence to derive public health evidence from large health datasets.

Jacqueline Postma – Jacqueline did her MSc in Biology (Utrecht University; 1995), a PhD in Environmental Sciences (Wageningen University; 2003), followed by post-doctoral studies in Plant Ecology (Lund University; 2007), after which she switched to her career at LUDC. She is project manager for the IMI project BEAt-DKD (https://www.beat-dkd.eu/), as she was previously for IMI-SUMMIT (2009-2015). Jacqueline will be supporting Maria Gomez in PRIME-CKD.

UKER

The Medical Clinic 4 – Nephrology and Hypertensiology at the University Hospital Erlangen represents a large research center for kidney diseases. It hosts the headquarter of the German Chronic Kidney Disease (GCKD) study, the worldwide largest CKD cohort study. The GCKD study has enrolled more than 5000 participants with CKD and has meanwhile followed them for more than 10 years. The study is designed to improve our understanding of the causes, variability and consequences of progressive kidney disease to identify new possibilities for diagnosis, prognostic stratification and therapy. Within the PRIME-CKD consortium GCKD will provide patient specimens for biomarker validation studies. 

People involved in Prime-CKD:

Kai-Uwe Eckardt (MD, Professor) is principal investigator of the GCKD study and full Professor at Charité, Berlin. He is a clinician scientist, qualified as physiologist and internist with a track record in both experimental and clinical research. His main research interests include the pathogenesis and progression of chronic kidney disease. Prof. Eckardt has also participated in large interventional trials in CKD patients and is since long actively involved in international efforts to optimise treatment strategies. 

Mario Schiffer (MD, Professor) is the director of the Medical Clinic 4 at the University Hospital Erlangen, Germany and member of the GCKD steering committee. He is a clinician scientist, qualified as nephrologist and internist with a track record of accomplishment in both experimental and clinical research. His main research interests are the identification of novel pathways in proteinuric human diseases like diabetes, glomerulonephritis and transplant glomerulopathy.

Prof. Schneider (Researcher)

Dr. Meiselbach (GCKD study coordinator)

HESS

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People involved in Prime-CKD:

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UMCG

The University Medical Center Groningen (UMCG) in the Netherlands is coordinating the PRIME-CKD project and will therefore be responsible for e.g., monitoring the overall scientific progress and quality of the project. In addition, UMCG will be in the lead of several tasks including the validation of analytical/clinical biomarker aspects; development of response scores for SGLT2i and ERA which can then be used in a prospective trial; analyzing and interpretating study data and preparing dissemination of the prospective trial; and seeking advice on biomarkers developed within the project by the European Medicines Agency’s (EMA) qualification of novel methodologies procedure. 

People involved in Prime-CKD:

Prof. Hiddo Lambers Heerspink will act as project coordinator. He is a clinical pharmacologist and trialist with ample expertise in clinical trial design, biomarkers, and personalized medicine.  He has a proven track record in the coordination of complex international research projects: he was co-leader of the IMI2 BEAt-DKD program and leads scientific steering committees of international trials such as the FIND-CKD and ALIGN trials. He is a renowned clinical trialist and was involved as principal investigator in the DAPA-CKD trial that led to the first drug registration for patients with CKD in two decades.

Jasper Stevens, PhD will act as Executive Director for the PRIME-CKD project. He has a background in biology, pharmacology, and pharmacometrics and is an expert on the development of non-linear Population Approach Pharmacokinetic and Pharmacodynamic models. 

Daphne Kuiper, PhD is an expert on implementation research and applied health research. She will support and guide efforts to guarantee successful clinical implementation of the results from the PRIME-CKD project.

Reinder Broekstra, PhD is an expert on ethical, legal, and social aspects (ELSA) of personalized medicine, in particular of applying innovative Information Communication Technologies (ICT). He is member of institutional, national, and international expert groups on ELSA of ICT and biomedical research. Additionally, he is affiliated with the Clinical Ethics and Law group of the University of Southampton/Oxford.

Ana Sauri Peris, PhD is an experienced project manager who works as a project manager at UMCG Research BV. She is involved in the post-award project management of this EU project as well as other consultancy UMCG internal projects. 

Erik Moedt is a PhD-candidate with a background in pharmacy, focused on biomarkers for personalized medicine in patients with diabetes and CKD. In PRIME-CKD he will be mainly working on the clinical validation of the pharmacodynamic response biomarkers in completed trials (WP2) and in a prospective trial (WP3).

UMCG_AndreRambelje

André de la Rambelje, PhD Candidate is a bioinformatician at the University Medical Center Groningen. He has experience in analyzing multi-omics data. His research will focus on understanding the pathophysiological aspects of disease and drug mechanisms. In PRIME-CKD, he will be involved in the clinical validation of the pharmacodynamic response biomarkers in completed clinical trials (WP2).

UMCG_AndreRambelje

Rémon Vos, PhD Candidate has a background in Biomedical Sciences and Clinical Chemistry and will use this experience as a researcher focusing on the clinical and analytical validation of the pharmacodynamic response biomarkers in CKD patients (WP1). Main focus of his thesis consists of the interest in the measurement of urinary proteins in clinical trials and clinical practice.

Renalytix

Renalytix is an in vitro diagnostics company, focused on development and translation to clinical practice of precision diagnostics tests for Chronic Kidney Disease in order to optimize clinical management leading to improved patient outcomes and lower healthcare costs.  We have developed the KidneyIntelX platform which combines data from blood or urine-based biomarkers with patient data from electronic health records to generate personalized assessment of risk of disease progression.   With operations located in Europe and US, Renalytix will play a leading role in translating the scientific and clinical research findings to diagnostics products for clinical use. 

People involved in Prime-CKD:

Fergus Fleming, Chief Technology Officer Fergus Fleming has served as Renalytix’s Chief Technical Officer since its inception. Fergus has over 30 years’ experience in the life sciences sector, including leadership positions with Baxter Healthcare, Boston Scientific, Trinity Biotech plc, and EKF Diagnostics. Fergus has extensive experience in the design and manufacture in vitro diagnostics instruments and reagents. 

Dr. Sharon Stapleton PhD, Director of Scientific and Clinical Research and Development. Sharon has over 15 years’ experience working with both early-stage start-ups and global diagnostics companies, including leadership positions with EKF Diagnostics, OncoMark (acquired by Cepheid Inc.) and Trinity Biotech. She is an expert in the design and development of immunoassays and has extensive experience managing multi-site projects including clinical studies, new product introduction and regulatory submissions. Dr Stapleton has a PhD in Applied Biochemistry from Dublin City University, Ireland.

Dr Katherine Edwards, Research and Development Scientist, Junior Researcher. Currently responsible for design, execution and reporting of development and validation studies for novel biomarkers in CKD.  Previously, Katherine was a product engineering scientist for Trinity Biotech plc. and was involved with new product transfer, validation of new products, clinical studies and regulatory submissions to the FDA and WHO, as well as, for CE marking.  Katherine’s PhD focused on exploring new regulators of innate immune signalling pathways with a particular focus on inflammasomes. 

Dr. Steven G. Coca, Nephrologist, is a Professor of Medicine and the Associate Chair for Clinical and Translational Research for the Department of Medicine at the Icahn School of Medicine at Mount Sinai. His research has focused on using novel biomarkers to improve risk stratification in patients with acute kidney injury and chronic kidney disease. Dr. Coca has been an active investigator in several large NIH-funded consortia (TRIBE-AKI, ASSESS-AKI, CKD Biocon, KPMP). He is a co-founder of Renalytix. 

Dr. Girish N. Nadkarni, Nephrologist, is the Fishberg Professor in Medicine at the Icahn School of Medicine at Mount Sinai, Chief of the Division of Data Driven and Digital Medicine (D3M) and Director of the Charles Bronfman Institute of Personalized Medicine. Dr. Nadkarni has authored 300 peer-reviewed scientific publications. He is the principal investigator for several NIH funded R01/U01 grants. Dr. Nadkarni is also the scientific co-founder of several investor-backed companies. 

CBG

Dutch Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen) is responsible for authorization and follow-up of medicinal products in the Netherlands and collaborates with the European Medicines Agency. In PRIME-CKD the CBG-MEB is responsible for WP 4 aimed at optimization of biomarker qualification procedures with regulatory agencies.

People involved in Prime-CKD:

Prof. Dr. Peter GM Mol, professor of drug regulatory science, University Medical Center Groningen, and senior clinical assessor at the CBG-MEB

Dr. Marjon (A.M.G.) Pasmooij, head of the science department, CBG-MEB

Dr. Viktoriia Starokozhko, clinical assessor, CBG-MEB

Lysbeth Bakker, PhD (-candidate)

Renkse Grupstra, PhD-candidate

MICHIGAN MEDICINE

The University of Michigan is the top public university in research spending in the United States. Aligned with the goal of its Medical School, the Michigan Kidney Translational Medicine Center (MiKTMC) is centered on integrated systems biology analysis of kidney diseases. Leveraging and integrating multi-omic, morhpometric data, and longidtudinal clincial information drived from patients with various kidney diseases, MiKTMC is building a roadmap to implementing precision medicine in nephrology clinical practice. 

People involved in Prime-CKD:

Wenjun Ju: PhD in molecular Biology. Lead contact of PRIME-CKD WP2. Dr. Ju is a Research Scientist in Department of Internal Medicine and Computational Medicine and Bioinformatics at UMICH. She has extensive experience in investigation of pathological mechanisms of CKD and non-invasive molecular mechanism-based biomarkers for kidney precision medicine. In PRIME-CKD, her responsibilities include leading the validation of the pharmacodynamic biomarkers in clinical trials (WP2) and working closely with colleagues from WP1 on the clinical-analytical evaluation of the biomarkers.

https://mcommunity.umich.edu/person/wenjunj
https://medicine.umich.edu/dept/dcmb/wenjun-ju-phd

Matthias Kretzler. MD. Dr. Kretzler is the Warner-Lambert/Park-Davis Professor of Medicine and Director MiKTMC at the University of Michigan. Dr. Kretzler is the co-lead of WP2. He is the PI of the Nephrotic Syndrome Research Network (NEPTUNE) and the Kidney Precision Medicine Project. He integrated a kidney-specific research focus with the unique bioinformatic environment at UMICH for successful implementation of precision medicine strategies of renal diseases, from bioinformatic data mining to successful completion of targeted therapies in Phase II trials. In PRIME-CKD, Dr. Kretzler will provide oversight into data integration.

Viji Nair PhD: Dr. Nair is the lead bioinformatician/computational biologist on the MiKTMC at University of Michigan. Her research focus is in identifying non-invasive biomarkers and therapeutic targets predicting disease progression in Diabetic Nephropathy and CKD in general. Dr. Nair leads the bioinformatic efforts in multi-omics data integration by adapting a wide variety of established and novel computational approaches. In PRIME-CKD, Dr.Nair works in WP2 focusing on the investigation of molecular mechanisms underlying the biomarkers of interest with treatment response. 

Emily Tanner:  received her Bachelor’s of Science from Michigan State University where she double majored in Genomics & Molecular Genetics and Microbiology with a specialization in Bioethics, Humanities, and Society. She joined MiKTMC in November 2017 and is now a Research Specialist. In PRIME-CKD, she is responsible for conducting biomarker measurements (WP2).

UMCG

MICHIGAN MEDICINE

CLV

Renalytix

UNIBO

CBG

Dutch Kidney Foundation

LUNDS UNIVERSITET

UNIVERSITY OF LEICESTER

HESS

REGION H

INCLIVA

UKE

UKER

UMCG

The University Medical Center Groningen (UMCG) in the Netherlands is coordinating the PRIME-CKD project and will therefore be responsible for e.g., monitoring the overall scientific progress and quality of the project. In addition, UMCG will be in the lead of several tasks including the validation of analytical/clinical biomarker aspects; development of response scores for SGLT2i and ERA which can then be used in a prospective trial; analyzing and interpretating study data and preparing dissemination of the prospective trial; and seeking advice on biomarkers developed within the project by the European Medicines Agency’s (EMA) qualification of novel methodologies procedure. 

People involved in Prime-CKD:

Prof. Hiddo Lambers Heerspink will act as project coordinator. He is a clinical pharmacologist and trialist with ample expertise in clinical trial design, biomarkers, and personalized medicine.  He has a proven track record in the coordination of complex international research projects: he was co-leader of the IMI2 BEAt-DKD program and leads scientific steering committees of international trials such as the FIND-CKD and ALIGN trials. He is a renowned clinical trialist and was involved as principal investigator in the DAPA-CKD trial that led to the first drug registration for patients with CKD in two decades.

Jasper Stevens, PhD will act as Executive Director for the PRIME-CKD project. He has a background in biology, pharmacology, and pharmacometrics and is an expert on the development of non-linear Population Approach Pharmacokinetic and Pharmacodynamic models. 

Daphne Kuiper, PhD is an expert on implementation research and applied health research. She will support and guide efforts to guarantee successful clinical implementation of the results from the PRIME-CKD project.

Reinder Broekstra, PhD is an expert on ethical, legal, and social aspects (ELSA) of personalized medicine, in particular of applying innovative Information Communication Technologies (ICT). He is member of institutional, national, and international expert groups on ELSA of ICT and biomedical research. Additionally, he is affiliated with the Clinical Ethics and Law group of the University of Southampton/Oxford.

Ana Sauri Peris, PhD is an experienced project manager who works as a project manager at UMCG Research BV. She is involved in the post-award project management of this EU project as well as other consultancy UMCG internal projects. 

Erik Moedt is a PhD-candidate with a background in pharmacy, focused on biomarkers for personalized medicine in patients with diabetes and CKD. In PRIME-CKD he will be mainly working on the clinical validation of the pharmacodynamic response biomarkers in completed trials (WP2) and in a prospective trial (WP3).

UMCG_AndreRambelje

André de la Rambelje, PhD Candidate is a bioinformatician at the University Medical Center Groningen. He has experience in analyzing multi-omics data. His research will focus on understanding the pathophysiological aspects of disease and drug mechanisms. In PRIME-CKD, he will be involved in the clinical validation of the pharmacodynamic response biomarkers in completed clinical trials (WP2).

UMCG_AndreRambelje

Rémon Vos, PhD Candidate has a background in Biomedical Sciences and Clinical Chemistry and will use this experience as a researcher focusing on the clinical and analytical validation of the pharmacodynamic response biomarkers in CKD patients (WP1). Main focus of his thesis consists of the interest in the measurement of urinary proteins in clinical trials and clinical practice.

MICHIGAN MEDICINE

The University of Michigan is the top public university in research spending in the United States. Aligned with the goal of its Medical School, the Michigan Kidney Translational Medicine Center (MiKTMC) is centered on integrated systems biology analysis of kidney diseases. Leveraging and integrating multi-omic, morhpometric data, and longidtudinal clincial information drived from patients with various kidney diseases, MiKTMC is building a roadmap to implementing precision medicine in nephrology clinical practice. 

People involved in Prime-CKD:

Wenjun Ju: PhD in molecular Biology. Lead contact of PRIME-CKD WP2. Dr. Ju is a Research Scientist in Department of Internal Medicine and Computational Medicine and Bioinformatics at UMICH. She has extensive experience in investigation of pathological mechanisms of CKD and non-invasive molecular mechanism-based biomarkers for kidney precision medicine. In PRIME-CKD, her responsibilities include leading the validation of the pharmacodynamic biomarkers in clinical trials (WP2) and working closely with colleagues from WP1 on the clinical-analytical evaluation of the biomarkers.

https://mcommunity.umich.edu/person/wenjunj
https://medicine.umich.edu/dept/dcmb/wenjun-ju-phd

Matthias Kretzler. MD. Dr. Kretzler is the Warner-Lambert/Park-Davis Professor of Medicine and Director MiKTMC at the University of Michigan. Dr. Kretzler is the co-lead of WP2. He is the PI of the Nephrotic Syndrome Research Network (NEPTUNE) and the Kidney Precision Medicine Project. He integrated a kidney-specific research focus with the unique bioinformatic environment at UMICH for successful implementation of precision medicine strategies of renal diseases, from bioinformatic data mining to successful completion of targeted therapies in Phase II trials. In PRIME-CKD, Dr. Kretzler will provide oversight into data integration.

Viji Nair PhD: Dr. Nair is the lead bioinformatician/computational biologist on the MiKTMC at University of Michigan. Her research focus is in identifying non-invasive biomarkers and therapeutic targets predicting disease progression in Diabetic Nephropathy and CKD in general. Dr. Nair leads the bioinformatic efforts in multi-omics data integration by adapting a wide variety of established and novel computational approaches. In PRIME-CKD, Dr.Nair works in WP2 focusing on the investigation of molecular mechanisms underlying the biomarkers of interest with treatment response. 

Emily Tanner:  received her Bachelor’s of Science from Michigan State University where she double majored in Genomics & Molecular Genetics and Microbiology with a specialization in Bioethics, Humanities, and Society. She joined MiKTMC in November 2017 and is now a Research Specialist. In PRIME-CKD, she is responsible for conducting biomarker measurements (WP2).

CLV

The CLV unit is involved in WP3 (prospective validation by RCT of the farmacodynamic response by biomarkers) and WP6 (Networking, communication, and exploitation).  Activity of this Nephrology Unit focuses on conservative therapy of CKD. Major mission is to delay ESKD by multifactorial therapy, including nutritional intervention and multi-drug approach.  Research includes observational and interventional studies, and meta-analyses. The Unit leads several national studies in Nephrology and has been involved in several international trials.  In particular, Investigators are recognized worldwide for the studies on the prognostic role of 24h blood pressure control in nondialysis CKD.

People involved in Prime-CKD:

Luca De Nicola is Full Professor in Nephrology and Director of Nephrology Unit and Postgraduate School of Nephrology at University of Campania, Naples, Italy, since 2019. His clinical and research activity is mainly dedicated to management of cardiorenal complications in non-dialysis CKD patients. He is author of almost 300 papers published on peer-reviewed internationa journals (H index 47), and he is/has been national leader of several RCTs on nephroprotection in CKD.

Roberto Minutolo is Associate Professor in Nephrology at University of Campania, Naples, Italy, since 2001. His clinical and research activity is mainly dedicated to management of complications in non-dialysis CKD patients. He is responsible for the outpatient clinic activities at Nephrology Division of University of Campania. He is author of more than 200 papers peer-reviewed published on main nephrology journals (H index 45) and he is/has been Member of the Editorial Boards for several journals.

Renalytix

Renalytix is an in vitro diagnostics company, focused on development and translation to clinical practice of precision diagnostics tests for Chronic Kidney Disease in order to optimize clinical management leading to improved patient outcomes and lower healthcare costs.  We have developed the KidneyIntelX platform which combines data from blood or urine-based biomarkers with patient data from electronic health records to generate personalized assessment of risk of disease progression.   With operations located in Europe and US, Renalytix will play a leading role in translating the scientific and clinical research findings to diagnostics products for clinical use. 

People involved in Prime-CKD:

Fergus Fleming, Chief Technology Officer Fergus Fleming has served as Renalytix’s Chief Technical Officer since its inception. Fergus has over 30 years’ experience in the life sciences sector, including leadership positions with Baxter Healthcare, Boston Scientific, Trinity Biotech plc, and EKF Diagnostics. Fergus has extensive experience in the design and manufacture in vitro diagnostics instruments and reagents. 

Dr. Sharon Stapleton PhD, Director of Scientific and Clinical Research and Development. Sharon has over 15 years’ experience working with both early-stage start-ups and global diagnostics companies, including leadership positions with EKF Diagnostics, OncoMark (acquired by Cepheid Inc.) and Trinity Biotech. She is an expert in the design and development of immunoassays and has extensive experience managing multi-site projects including clinical studies, new product introduction and regulatory submissions. Dr Stapleton has a PhD in Applied Biochemistry from Dublin City University, Ireland.

Dr Katherine Edwards, Research and Development Scientist, Junior Researcher. Currently responsible for design, execution and reporting of development and validation studies for novel biomarkers in CKD.  Previously, Katherine was a product engineering scientist for Trinity Biotech plc. and was involved with new product transfer, validation of new products, clinical studies and regulatory submissions to the FDA and WHO, as well as, for CE marking.  Katherine’s PhD focused on exploring new regulators of innate immune signalling pathways with a particular focus on inflammasomes. 

Dr. Steven G. Coca, Nephrologist, is a Professor of Medicine and the Associate Chair for Clinical and Translational Research for the Department of Medicine at the Icahn School of Medicine at Mount Sinai. His research has focused on using novel biomarkers to improve risk stratification in patients with acute kidney injury and chronic kidney disease. Dr. Coca has been an active investigator in several large NIH-funded consortia (TRIBE-AKI, ASSESS-AKI, CKD Biocon, KPMP). He is a co-founder of Renalytix. 

Dr. Girish N. Nadkarni, Nephrologist, is the Fishberg Professor in Medicine at the Icahn School of Medicine at Mount Sinai, Chief of the Division of Data Driven and Digital Medicine (D3M) and Director of the Charles Bronfman Institute of Personalized Medicine. Dr. Nadkarni has authored 300 peer-reviewed scientific publications. He is the principal investigator for several NIH funded R01/U01 grants. Dr. Nadkarni is also the scientific co-founder of several investor-backed companies. 

UNIBO

Alma Mater Studiorum University of Bologna (UNIBO) and IRCCS Azienda Ospedaliero-Universitaria of Bologna are partecipating to the project PRIME-CKD. These entities will be involved in WP1, WP3, WP5, WP6, WP7. Thus, UNIBO and IRCCS will contribute to patients recruitment for the UVALID and CKD-bioMatch clinica studies and will be involved into the dissemination of results more specific for WP-5 to WP-7.

People involved in Prime-CKD:

Prof. Gaetano La Manna, MD, PhD
-Professor of Nephrology at University of Bologna
-Director of Nephrology Division at IRCCS Azienda Ospedaliero-Universitaria di Bologna.
-Principal investigator for Alma Mater Studiorum University of Bologna and IRCCS Azienda Ospedaliero-Universitaria of Bologna.

Dr. Michele Provenzano, MD, PhD:
-Junior Assistant Professor
-Researcher at University of Bologna
-Sub-investigator for Alma Mater Studiorum University of Bologna and IRCCS Azienda Ospedaliero-Universitaria of Bologna.

Dr. Giorgia Comai, MD, PhD
-Head of Kidney Transplant Unit at IRCCS Azienda Ospedaliero-Universitaria di Bologna
-Sub-investigator for Alma Mater Studiorum University of Bologna and IRCCS Azienda Ospedaliero-Universitaria of Bologna.

Prof. Irene Capelli, MD, PhD:
-Associate Professor of Nephrology at University of Bologna
-Sub-investigator for Alma Mater Studiorum University of Bologna and IRCCS Azienda Ospedaliero-Universitaria of Bologna.

Dr. Lilio Hu, MD:
-PhD Student in Nephrology
-Sub-investigator for Alma Mater Studiorum University of Bologna and IRCCS Azienda Ospedaliero-Universitaria of Bologna.

CBG

Dutch Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen) is responsible for authorization and follow-up of medicinal products in the Netherlands and collaborates with the European Medicines Agency. In PRIME-CKD the CBG-MEB is responsible for WP 4 aimed at optimization of biomarker qualification procedures with regulatory agencies.

People involved in Prime-CKD:

Prof. Dr. Peter GM Mol, professor of drug regulatory science, University Medical Center Groningen, and senior clinical assessor at the CBG-MEB

Dr. Marjon (A.M.G.) Pasmooij, head of the science department, CBG-MEB

Dr. Viktoriia Starokozhko, clinical assessor, CBG-MEB

Lysbeth Bakker, PhD (-candidate)

Renkse Grupstra, PhD-candidate

Dutch Kidney Foundation

The Dutch Kidney Foundation is a health charity, founded in 1968. Our mission is to inspire and stimulate people to join us in our efforts towards a world without kidney disease and a better future for kidney patients.

We support scientific research, advocate kidney health for the general public and invest in patient education and social participation for kidney patients.

 In the PRIME-CKD project the Dutch Kidney Foundation is responsible for networking, communication and exploitation of results through a stakeholder network that assists in the translation of research findings and implementation in clinical practice. 

People involved in Prime-CKD:

Dr. Stijn Gremmen is Work Package Leader for WP6 in the PRIME-CKD consortium and as such involved in networking and communication of results.

Stijn is working as Program Manager at the Dutch Kidney Foundation and involved in funding of scientific research and development projects. Previously, he has worked on complex chemistry problems in industrial drug discovery projects at several contract research organizations (2004 – 2021). He holds a PhD in bioorganic chemistry (University of Amsterdam, 2002). 

LUNDS UNIVERSITET

The participants from Lund University (ULUND) are members of the Lund University Diabetes Centre (LUDC), with ~320 staff members working towards improved diagnosis, prevention and treatment of diabetes. They are located at the Clinical Research Centre of the University, in close connection to the Skåne University Hospital, creating the ideal setting for both basic and clinical research.  

ULUND will participate primarily in WP3 and WP5 activities and to a minor extent in WP6 and WP7. Prof Maria F. Gomez will act as PRIME-CKD vice coordinator, working closely with the coordinator.   

People involved in Prime-CKD:

Maria F. Gomez – Professor of Physiology at the Department of Clinical Sciences, Director of Lund University Diabetes Centre (http://www.ludc.lu.se) and Honorary Skou Professor at the Faculty of Health, Aarhus University, Denmark. After medical school, she completed her Ph.D. in physiology (Lund University; 1998) and post-doctoral studies in Pharmacology (University of Vermont; 2001). She has published ~136 papers and supervised 11 PhD theses, 13 post-docs and >30 students. She’s coordinator of IMI project BEAt-DKD (https://www.beat-dkd.eu/) and vice-coordinator of PRIME-CKD. 

Anders Christensen – Professor of Nephrology at the Department of Clinical Sciences Malmo, Lund University and Head physician of Nephrology at Skåne University Hospital, Malmö, Sweden. After medical school he completed his PhD in clinical chemistry (Lund University 1993). Postdoc at Rockefeller University, MSKCC, New York. His research is focused on GFR-markers, chronic kidney disease, protein research and epidemiology. He has published 100 papers and supervised 7 PhD theses. He is program director for renal care in Sweden. 

Christopher Nilsson – Post doc at the Department of Clinical Sciences Malmo, Lund University. After graduating from medical school at Lund University in 2017, he completed his Ph.D. in internal medicine (Lund University; 2021) focusing on the relationship between ethnicity, blood pressure and renal function. He is currently undergoing his medical residency in Internal medicine and Nephrology at Skåne University Hospital, Malmo. 

Abrar Ahmad – Postdoc at the Department of Clinical Sciences Malmo, Lund University. After graduating from veterinary school at University of Agriculture Faisalabad, Pakistan, he completed his master’s degree in Molecular Medical Biology at Örebro University, Sweden in 2012 and his Ph.D. in medical sciences at Lund University in 2018. His Ph.D. project focused on the identification of genetic biomarkers for the risk prediction of recurrent venous thromboembolism. He has published ~17 papers in the fields of cancer, cardiovascular diseases, and diabetes. 

Hugo Fitipaldi – Postdoctoral Fellow at the Department of Clinical Sciences, Lund University. Hugo Fitipaldi holds a BSc in Physiotherapy from Universidade Federal de Pernambuco (2013) and an MSc in Public Health (MPH) from Lund University (2018). He completed his PhD at the Lund University Diabetes Centre (2023), where he focused on the application of data mining and artificial intelligence to derive public health evidence from large health datasets.

Jacqueline Postma – Jacqueline did her MSc in Biology (Utrecht University; 1995), a PhD in Environmental Sciences (Wageningen University; 2003), followed by post-doctoral studies in Plant Ecology (Lund University; 2007), after which she switched to her career at LUDC. She is project manager for the IMI project BEAt-DKD (https://www.beat-dkd.eu/), as she was previously for IMI-SUMMIT (2009-2015). Jacqueline will be supporting Maria Gomez in PRIME-CKD.

UNIVERSITY OF LEICESTER

The University of Leicester hosts the Kidney Research Team which is led by Professor Jonathan Barratt. We have extensive laboratory facilities to study kidney disease from the single cell to highly complex models using cutting edge technologies. The John Walls Renal Unit at the University Hospitals of Leicester NHS Trust looks after kidney patients with all forms of kidney disease and has a very active clinical trials unit. The Hospital and University teams work very closely together to ensure that we are able to offer our patients the opportunity to get involved in a large range of research studies, including clinical trials of the newest therapies. 

People involved in Prime-CKD:

Professor Jonathan Barratt & Dr Chee Kay Cheung are clinician scientists who undertake bench to bedside research into the causes and treatment of kidney diseases that affect the fine filters (glomeruli) of the kidneys. They have a major interest in IgA nephropathy, the commonest cause of glomerular disease in the world. This disease mostly affects young adults and commonly causes kidney failure. We have an active clinical trial program running at the John Walls Renal Unit where we treat patients with glomerular disease and a large laboratory facility at the University of Leicester where we study different experimental models of kidney damage. 

HESS

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People involved in Prime-CKD:

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REGION H

Steno Diabetes Center Copenhagen (SDCC) is specialized in patient care, research, prevention of diabetes, and educating healthcare professionals working with diabetes. SDCC is the largest diabetes clinic in Scandinavia, treating annually more than 11,000 people with diabetes from the Capital Region of Denmark. SDCC aims to offer world-class treatment and contribute to a better life and health quality for people with diabetes, their relatives, and citizens at risk. 

In PRIME-CKD SDCC act as a lead partner in WP3 and as a participating partner in WP1, 4, 6 and 7.

People involved in Prime-CKD:

Peter Rossing, Professor, MD, DMSc, Head of Complications Research SDCC

Clinician researcher in diabetic complications, focusing on complications of the kidney and cardiovascular system, but also diabetic nerve damage and foot ulcers. Involved in several EU projects, and in clinical trials with new treatments that may be promising for preventing and treating diabetic complications.
Responsibilities in PRIME-CKD include, but are not limited to: 
– Sponsor/lead in WP3
– SDCC Principal investigator in WP1 and WP3.

Frederik Persson, Senior Researcher, MD, DMSc

Research in diabetic complications, focusing on diabetic nephropathy.
Responsibilities in PRIME-CKD include, but are not limited to: 
– Co-lead and ethical coordinator in WP3.  

Marte Opseth Rygg, Ph.d. student, MD

Research in diabetic complications, focusing on diabetic nephropathy. 
Responsibilities in PRIME-CKD: sub-investigator in WP1 and WP3.

INCLIVA

INCLIVA Health Research Institute manages biomedical research carried out by the Hospital Clínico Universitario in Valencia and its Health Department, as well as certain scientific excellence groups from the Faculty of Medicine at the University of Valencia and the Carlos Simon Foundation.

Our team is included in the Research Group on the Study of Cardiometabolic and Renal Risk of INCLIVA.Our Renal Clinical trials Unit has experience in more than 40 studies in patients with chronic kidney disease and dialysis. The team is formed of 4 nephrologist , 1 study nurse/ study coordinator, one data manager and we collaborate with CEU Cardenal Herrera University in the training of new clinical trial staff. In addition, we also carry own and industry trials.

Dr. Gorriz

Dr Gorriz is Head of the Nephrology Department in the Clinic University Hospital, Valencia, Spain. He is alsoAssistant Professor of Nephrology at the Faculty of Medicine, Valencia. He is especially dedicated to the field ofclinical nephrology; research areas include chronic kidney disease, diabetic kidney disease, renal progression.

He is one of the coordinators of The Spanish Study Group for Diabetic Nephropathy (GEENDIAB). He has participated as Principal Investigator in more than 20 clinical trials on diabetic kidney disease and has been a National Leader for the studies BEACON (bardoxolone), CREDENCE (canagliflozin), DAPA CKD (dapagliflozin) and FLOW (semaglutide in patients with CKD).

Dr Gorriz is skilled in medical informatics and has used large databases and web technology to coordinate severalmulticentre studies. Dr Gorriz was the Secretary of the Spanish Society of Nephrology from 2008–2014 and is currently President of The Valencian Society of Nephrology.

Lorena Gandía

Study Coordinator / Staff Nurse

Dr. Moncho

Senior associate resident. Sub-Investigator

UKE

The III. Department of Medicine at the University Medical Center Hamburg-Eppendorf is dedicated to the care of patients and to experimental and clinical kidney research with a number of national and international collaborations and internationally leading research programs aiming to identify mechanisms and new treatment options for various human kidney diseases. As part of PRIME CKD, the UKE is leading an international study validating analytical aspects relevant for the clinical measurement of biomarker-based tests to predict the response of patients with CKD to existing drugs.

People involved in Prime-CKD:

Tobias B Huber (Prof., MD)

Chair of the Center of Internal Medicine, UKE, Hamburg, Germany
Director of the III. Department of Medicine, UKE, Hamburg, Germany
Project Leader WP1/ Clinical Head

Maja Lindenmeyer (PD, PhD)

Laboratory Head/Head OF Biobank at the III. Department of Medicine, UKE, Hamburg, Germany
Deputy Study Coordinator UVALID Study

Elisabeth Meister (MD)

Clinician scientist at the III. Department of Medicine, UKE, Hamburg, Germany
Study Coordinator UVALID Study

UKER

The Medical Clinic 4 – Nephrology and Hypertensiology at the University Hospital Erlangen represents a large research center for kidney diseases. It hosts the headquarter of the German Chronic Kidney Disease (GCKD) study, the worldwide largest CKD cohort study. The GCKD study has enrolled more than 5000 participants with CKD and has meanwhile followed them for more than 10 years. The study is designed to improve our understanding of the causes, variability and consequences of progressive kidney disease to identify new possibilities for diagnosis, prognostic stratification and therapy. Within the PRIME-CKD consortium GCKD will provide patient specimens for biomarker validation studies. 

People involved in Prime-CKD:

Kai-Uwe Eckardt (MD, Professor) is principal investigator of the GCKD study and full Professor at Charité, Berlin. He is a clinician scientist, qualified as physiologist and internist with a track record in both experimental and clinical research. His main research interests include the pathogenesis and progression of chronic kidney disease. Prof. Eckardt has also participated in large interventional trials in CKD patients and is since long actively involved in international efforts to optimise treatment strategies. 

Mario Schiffer (MD, Professor) is the director of the Medical Clinic 4 at the University Hospital Erlangen, Germany and member of the GCKD steering committee. He is a clinician scientist, qualified as nephrologist and internist with a track record of accomplishment in both experimental and clinical research. His main research interests are the identification of novel pathways in proteinuric human diseases like diabetes, glomerulonephritis and transplant glomerulopathy.

Prof. Schneider (Researcher)

Dr. Meiselbach (GCKD study coordinator)