Rethinking kidney trials: The ISN’s PARADIGM roadmap moves into action
Kidney disease research is entering a pivotal moment. Kidney International® published the ISN PARADIGM paper, “Changing paradigms of studies in kidney diseases,” outlining a global roadmap to modernize how kidney trials are designed and conducted — with patients, equity, and real-world relevance at the center.
What the PARADIGM paper delivers
The article is based on outcomes from the two-day international consensus meeting convened by the ISN, bringing together clinicians, trialists, patient partners, regulators, and industry partners. Recommendations include:
- Making trials more inclusive by improving access and participation for underrepresented groups and regions.
- Using validated, culturally appropriate patient-reported outcomes to ensure trials measure outcomes that matter most to patients.
- Adopting innovative trial designs to speed up progress and broaden participation.
- Strengthening global collaboration through shared networks, data infrastructures, and coordinated research efforts.
These recommendations aim to make future kidney trials more rigorous, more relevant, and more globally applicable by calling for a fundamental shift in kidney trial design.
Find out more about the PARADIGM meeting
What the global roadmap aims to achieve
The PARADIGM roadmap outlines a coordinated strategy to help the research community:
- Broaden trial access in low-resource settings
- Adopt patient-centered endpoints with validated PROMs and composite measures
- Use modern trial methodologies from adaptive designs to embed real-world evidence
- Build collaborative networks across regions and sectors
- Ensure research translates into practice to improve care worldwide
PARADIGM podcast series: Insights from global leaders
“One of the great things about that meeting was the opportunity to hear from our patient partners… one of the big messages we hear is that they want data on how our interventions are affecting the way they feel and function in their day-to-day lives.” Kevin Weinfurt
To support a wider understanding of the roadmap, the ISN has produced a two-episode podcast on PARADIGM, featuring global experts, including Adeera Levin, Hiddo Heerspink, and Kevin Weinfurt. Episode 1 discusses how kidney trials can evolve to serve people living with kidney disease better and drive meaningful outcomes.
Episode 2, on putting change into practice, will be available shortly.
Join the PARADIGM discussion at WCN’26
A dedicated session at WCN’26, “Innovating Kidney Trials: PROMs, New Designs, and Global Roadmaps,” will present the key outcomes of the consensus meeting and explore practical insights for researchers, clinicians, industry partners, and policymakers working to advance kidney trial methodology:
- The complexity of kidney diseases
- Integrating PROMs into trial frameworks
- Innovative trial designs and hierarchical composite endpoints
- Priorities for global research
The PARADIGM initiative represents a significant step toward more meaningful, patient-centered kidney research. We encourage the ISN community to explore the recommendations, listen to the podcast, and join the dedicated session at WCN’26 to help advance this shared commitment to raising the standard of kidney trials worldwide.
