Hiddo J L Heerspink, Lesley A Inker, Hocine Tighiouart, Willem H Collier, Benjamin Haaland, Jiyu Luo, Gerald B Appel, Tak Mao Chan, Raymond O Estacio, Fernando Fervenza, Jürgen Floege, Enyu Imai, Tazeen H Jafar, Julia B Lewis, Philip Kam-Tao Li, Francesco Locatelli, Bart D Maes, Annalisa Perna, Ronald D Perrone, Manuel Praga, Francesco P Schena, Christoph Wanner, Di Xie, Tom Greene
SIGNIFICANCE STATEMENT: Changes in albuminuria and GFR slope are individually used as surrogate end points in clinical trials of CKD progression, and studies have demonstrated that each is associated with treatment effects on clinical end points. In this study, the authors sought to develop a conceptual framework that combines both surrogate end points to better predict treatment effects on clinical end points in Phase 2 trials. The results demonstrate that information from the combined treatment effects on albuminuria and GFR slope improves the prediction of treatment effects on the clinical end point for Phase 2 trials with sample sizes between 100 and 200 patients and duration of follow-up ranging from 1 to 2 years...
June 1, 2023: Journal of the American Society of Nephrology: JASN