Application of a Kidney Hierarchical Composite Endpoints in Trials of CKD Progression: Report of a Scientific Workshop Sponsored by the National Kidney Foundation
In brief
Kidney experts propose ranked endpoints to make progression trials more efficient
A National Kidney Foundation workshop proposed combining death, kidney failure, sustained drops in kidney function and its rate of decline, ranked by clinical importance. The approach could help test therapies in patients at risk of progression when traditional trials would have too few clinical events, but it is not suited to every trial. Researchers still need to resolve how best to compare kidney function decline.
- Journal
- American journal of kidney diseases : the official journal of the National Kidney Foundation (Q1)
- Published
- 22 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Lesley A Inker, Tom Greene, Glenn M Chertow, Kelli Collins Damron, Julie F Furberg, Samvel B Gasparyan, et al.
- PMID
- 42772350
- DOI
- 10.1053/j.ajkd.2026.06.017
Why clinicians should know about it
- Picked for Nephrology (top studies of the week, 27 September 2026): Kidney hierarchical composite endpoints for CKD trials
Abstract
Despite approved therapies for chronic kidney disease (CKD), many patients experience progressive loss of kidney function, and there remains an unmet need for additional therapies. Hierarchical composite endpoints (HCEs) have emerged as candidate tools to improve the efficiency of randomized controlled trials (RCTs) by integrating multiple outcomes ranked by clinical importance. The National Kidney Foundation convened a Scientific Workshop involving a broad group of stakeholders to consider the application of HCEs to CKD. A proposed kidney HCE includes all-cause mortality, kidney failure with or without initiation of kidney replacement therapy, time to sustained declines in GFR, and GFR slope. Workshop participants concluded that a kidney HCE is a promising candidate for establishing efficacy of therapies in settings in which we typically conduct large trials that use kidney composite endpoints to establish efficacy. It was acknowledged that no endpoint is universally applicable in all situations. The ideal population for an HCE would be one at risk for progression but unlikely to yield sufficient clinical events during the trial period to permit application of the traditional time-to-event endpoint. Additional investigations are required to address key challenges in application of HCE to CKD, such as how to best assess differences in individual GFR slope.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.