Development and Validation of a New Hierarchical Composite Endpoint for Clinical Trials of Kidney Disease Progression.
Hiddo J Lambers HeerspinkNiels JongsPatrick SchloemerDustin J LittleMeike BrinkerChristoph TastoMartin KarpeforsDavid C WheelerGeorge L BakrisVlado PerkovicRichard NkulikiyinkaJerome RossertSamvel B GasparyanPublished in: Journal of the American Society of Nephrology : JASN (2023)
In seven major kidney clinical trials, the WO and HR provided similar direction of treatment effect estimates with smaller HRs associated with larger WOs. The prioritization of clinical outcomes and inclusion of broader composite endpoints makes the HCE an attractive alternative to the established kidney endpoint.