Change in Albuminuria and GFR Slope as Joint Surrogate End Points for Kidney Failure: Implications for Phase 2 Clinical Trials in CKD.
Journal of the American Society of Nephrology : JASN（2023）
摘要
In Phase 2 trials of CKD with sample sizes of 100-200 patients per arm and follow-up between 1 and 2 years, combining information from treatment effects on UACR change and GFR slope improved the prediction of treatment effects on clinical end points.
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关键词
surrogate end point, albuminuria, glomerular filtration rate, kidney failure, clinical trial, biomarkers, chronic kidney disease
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