PRIME-CKD Annual Stakeholder Meeting 2025 

On 13 May 2025, the PRIME-CKD consortium organised a meeting for the consortium’s stakeholders. Principal investigator Hiddo Lambers Heerspink and Stijn Gremmen presented the progress across the project’s work packages, highlighting developments in biomarker research and personalized treatment strategies for chronic kidney disease (CKD).

Work package highlights

In Work Package 1 the clinical validation of various biomarkers concluded that EGF (Epidermal Growth Factor) is a biomarker that is stable over longer periods and easy to measure. Detailed findings will be presented at the ASN Kidney Week in november 2025.

In Work Package 3 the prospective CKD-Biomatch clinical trial has received ethics approval and the first site in Copenhagen is initiated. The study will compare a biomarker based strategy using standard-of-care treatments (finerenone, dapagliflozin, and semaglutide) with care as usual. Urinary EGF will be used as one biomarker to guide treatment.

Work Package 4 aims to investigate the regulatory aspects of biomarker-guided treatment for CKD. To get better insights in bottle necks for implementation, detailed interviews were conducted with regulators, clinicians, patients and pharmaceutical companies. The outcomes of these 49 interviews will provide a wealth of information that highlight opportunities and bottle necks for the use of biomarkers in the field of chronic kidney disease.

In the past year patients were actively involved in the development of patient information material for the CKD-Biomatch trial (Work Package 3). Moreover, they were of great help to the PRIME-CKD consortium by suggesting improvements of a survey that investigates the patient perspective on biomarker guided treatment of CKD.

Discussion highlights

Discussions with the stakeholders focused on the practical use of biomarkers in treatment selection. Concerns were raised about overly broad threshold ranges for clinical use, the distinction between predictive and prognostic value of biomarkers, and their use in risk stratification or assessing treatment response. It was emphasized that clarity of purpose of biomarker use is essential for clinical and regulatory acceptance.

The ethical complexity of excluding patients from guideline treatments in clinical trials was also discussed. This mirrors past debates in other therapeutic areas and may offer valuable learning opportunities for the implementation of biomarker guided treatment in CKD.

To conclude, Hiddo announced that a larger two day stakeholder conference is scheduled for 2027. In the coming years we will continue with general stakeholder meetings and meetings with particular groups of stakeholders around specific discussion points.

We thank all the stakeholders in our network for their valuable contributions to ensure that PRIME-CKD outcomes are actually implemented in practice!

Do you want to join our growing stakeholder network? Please follow us on LinkedIn (https://www.linkedin.com/company/prime-ckd/) or reach out to us via primeckd@nierstichting.nl