Change in Albuminuria and GFR Slope as Joint Surrogate Endpoints for Kidney Failure: Implications for Phase 2 Clinical Trials in CKD.
Hiddo J Lambers HeerspinkLesley A InkerHocine TighiouartWillem H CollierBenjamin HaalandJiyu LuoGerald B AppelTak Mao ChanRaymond O EstacioFernando FervenzaJürgen FloegeEnyu ImaiTazeen H JafarJulia B LewisPhilip Kam-Tao LiFrancesco LocatelliBart D MaesAnnalisa PernaRonald D PerroneManuel PragaFrancesco P SchenaChristoph WannerDi XieTom GreenePublished in: Journal of the American Society of Nephrology : JASN (2023)
In phase 2 trials of CKD with sample sizes of 100 to 200 patients per arm and follow-up between 1 and 2 years, combining information from treatment effects on UACR change and GFR slope improved prediction of treatment effects on clinical endpoints.