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Optimizing Sample Size Calculation for Early-Stage CKD Trials Using eGFR Slope.

2026-06-09, Journal of the American Society of Nephrology : JASN (10.1681/ASN.0000001157) (online)
Kenta Murotani, Tetsuo Saito, and Tetsuya Ioji (?)
In CKD trials, the eGFR slope has emerged as a surrogate endpoint for earlier assessment of treatment effects. However, the influence of key design parameters-slope difference, trial duration, measurement frequency, and dropout patterns-on the required sample size remains unclear. We aimed to derive a sample size formula that incorporated these factors and develop a practical tool for efficient calculation across diverse trial scenarios.
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