WP1: Analytical and clinical validation of the pharmacodynamic response biomarkers in CKD patients.

Work package 1

Universitaetsklinikum Hamburg -Eppendorf

Elisabeth Meister / Tobias Huber

In Work Package 1 PRIME-CKD aims to conduct a prospective observational study in 60 patients with CKD of mixed sexes and ethnicities to validate the proposed biomarkers from an analytical perspective. The proposed biomarkers predicting drug response to ERAs (urinary clusterin and plasminogen) and SGLT2 inhibitors (urinary EGF) are validated according to FDA standards (CDER 2018) and can be accurately measured in human samples. However, analytical aspects in relation to the use of the biomarkers as companion diagnostics to establish drug efficacy requires further clinical-analytical validation in order to close the gap between biomarker research and clinical implementation.

Objectives of this work package:

To recruit patients with CKD of mixed sexes and ethnicities for a prospective observational validation study.

To validate the proposed biomarkers from an analytical perspective, intra-individual day-to-day variability, and effect of prolonged frozen storage.

To determine biomarker levels in males and females and populations of mixed ethnicities and 24-hr circadian rhythm of the urinary biomarkers.

Participants:

Universitaetsklinikum Hamburg -Eppendorf

University Medical Center Groningen

University of Michigan,

Region Hovedstaden – Steno Diabetes Center Copenhagen

Fundacion para la Investigacion del Hospital Clinico de la Comunidad Valenciana – Fundacion INCLIVA

Alma Mater Studiorum – Universita di Bologna

IRCCS Azienda Ospedaliero – Universitaria di Bologna

Hessels en Grob BV.

WP1: Analytical and clinical validation of the pharmacodynamic response biomarkers in CKD patients.

Work package 1

Universitaetsklinikum Hamburg -Eppendorf

Elisabeth Meister / Tobias Huber

Objectives of this work package:

Participants:

EU FUNDING

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