The stakeholder network of the PRIME-CKD consortium plays an important role in advancing biomarker research for chronic kidney disease (CKD). Over the past year, patient representatives, medical professionals, industrial partners, and regulatory organizations have worked closely together to shape the direction of biomarker research for chronic kidney disease (CKD). Stakeholders have recently provided valuable input in two keyways, guiding both the strategic direction and practical execution of research initiatives.

A primary objective of PRIME-CKD is to develop a comprehensive roadmap for biomarker research, with a particular focus on CKD patients. To achieve this, the consortium has been proactively identifying opportunities and addressing bottlenecks in biomarker research before the clinical trials start.

Gathering Stakeholder Insights

In mid-2024, interviews were conducted with over 50 stakeholders – including patient representatives, regulators, health technology assessment (HTA) specialists, medical professionals, and representatives from pharmaceutical companies. The aim of the interviews was to gather insights into stakeholders’ experiences with the development and clinical implementation of biomarker thresholds. Results from the analysis of the interviews will be published in 2025.   

Incorporating Patient Perspectives

During the development of the interview study protocol, patient organizations emphasized the need for a tailored approach to better capture patients’ perspectives. In response, a follow-up project was initiated to explore patient needs and preferences regarding biomarker-driven treatments.

“Through this new project, we aim to understand CKD patients’ needs and preferences for biomarker-driven trials and therapies. By surveying CKD patients, we hope to gain valuable insights into what they consider most important,” explains Renske Grupstra, PhD student at the Dutch Medicines Evaluation Board.

Building on these efforts, researchers focused on refining response cards to be used in the upcoming CKD-bioMatch trial, planned for 2025. Patient representatives, engaged through the Dutch Kidney Foundation, provided essential feedback that helped shape these materials. In November 2024, a meeting with the PRIME-CKD patient board allowed researchers to present two CKD-bioMatch response card prototypes. Based on participant feedback, adjustments were made to improve the design and usability of the cards.

“I was very happy with the meeting—we had a productive discussion and received valuable input on the response cards,” says Marte Opseth Rygg, Ph.D. student and MD at the Steno Diabetes Center Copenhagen. “The feedback helped us refine and further develop the content.”

Bridging Research and Patient Needs

These collaborative efforts aim to understand what matters most to stakeholders and patients in particular when designing biomarker-driven trials for kidney diseases. By integrating patient perspectives early in the process, PRIME-CKD researchers hope to create studies that are both effective and patient-centered.

Carine Besselink, a patient representative and member of the Dutch patient advisory council on medication, highlights the importance of collaboration: “It is so important that we, as patients, can participate from the start of a study all the way through implementation, instead of only during the clinical trials.”

With continued interdisciplinary cooperation between researchers, patients and other stakeholders, PRIME-CKD hopes to pave the way for impactful advancements in CKD research.