Objectives of this work package:
- To validate the pharmacodynamic biomarkers in samples of patients from SGLT2i and ERA clinical trials and clinical practice database for their potential to predict long term drug efficacy on kidney outcomes.
- To develop response scores for SGLT2i and ERA which can be used for the prospective CKD-bioMatch trial (WP-3).
- To determine molecular mechanisms underlying the association of biomarkers and treatment response.
To demonstrate that these biomarkers translate directly to clinical care, the biomarkers will also be measured in German CKD, a high-quality world-renowned observational study with 11 years follow-up. The duration of the project and the available budget for PRIME-CKD is insufficient to conduct a prospective clinical endpoint trial. The PRIME-CKD project therefore leverages and combines this unique bio-repository with the conduct of a prospective clinical trial using a surrogate endpoint to efficiently validate the pharmacodynamic response biomarkers within the 5-year’s time frame of the program.
Participants:
- University of Michigan
- University Medical Center Groningen
- University of Leicester
- Universitatsklinikum Erlangen
- Renalytix AI Limited
- Universitaetsklinikum Hamburg -Eppendorf
