WP3: Clinical validation of the pharmacodynamic response biomarkers in a prospective novel clinical trial.
Work package 3
Region Hovedstaden – Steno Diabetes Center Copenhagen
Peter Rossing / Frederik Persson
In Work Package 3 PRIME-CKD aims to test the personalized medicine with a prospective validation trial (CKD-bioMatch). The primary objective of CKD-bioMatch is to demonstrate that a biomarker response guided therapy approach compared to care as usual will lead to a more pronounced reduction in albuminuria as surrogate endpoint for kidney failure. The biomarker guided treatment arm comprises the characterization of drug response using the pharmacodynamic biomarkers (EGF, clusterin, plasminogen). Based on the response in these biomarkers together with albuminuria a response score will be generated, based on input from WP2, and a decision be made to continue treatment, to switch to a new treatment, or to add a new therapy.
Objectives of this work package:
- To develop and prepare the CKD-bioMatch clinical trial protocol in accordance with requirements Good Clinical Practice (GCP) and considering GCP investigator training, biosample and medication shipment logistics, database and eCRF development, and monitoring activities
- To conduct the CKD-bioMatch trial according to the study protocol and planned timelines.
- To analyze and interpret clinical trial results and if primary objective is met transition control arm to biomarker guided treatment.
Participants:
- Region Hovedstaden – Steno Diabetes Center Copenhagen
- University Medical Center Groningen
- Lunds Universitet
- Universitaetsklinikum Hamburg -Eppendorf
- University of Campania “Luigi Vanvitelli”
- University of Leicester
- University Hospitals of Leicester NHS Trust
- Alma Mater Studiorum – Universita di Bologna
- IRCCS Azienda Ospedaliero – Universitaria di Bologna
- Hessels en Grob BV
- Fundacion para la Investigacion del Hospital Clinico de la Comunidad Valenciana – Fundacion INCLIVA.
