ISSN 1006-298X      CN 32-1425/R

Chinese Journal of Nephrology, Dialysis & Transplantation ›› 2022, Vol. 31 ›› Issue (6): 556-560.DOI: 10.3969/j.issn.1006-298X.2022.06.012

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Implication of GFR slope as a surrogate end point in clinical trials

  

  • Online:2022-12-28 Published:2023-01-04

Abstract: In clinical trial design, selection of appropriate end point is one of the key factors that determine the success of the study. Due to the features of insidious onset and slow progression, clinical trials in chronic kidney diseases often require larger sample size, longer followup periods, or patients with rapidly progressive or latestage disease, to obtain sufficient end points when using endstage kidney disease or doubling of serum creatinine as renal outcomes. And this has greatly restricted development of new drugs in kidney disease. In 2014, a 30% or 40% decrease in glomerular filtration rate (GFR) in a certain period was proposed as a surrogate end point. However, its application value is limited in patients with high baseline GFR. In recent years, studies have shown that GFR slope can be used as a surrogate end point for populations at early stages of disease. In this review, we discuss the options of renal endpoints as well as GFR slope as a surrogate end point in clinical trials.


Key words: glomerular filtration rate slope, clinical trial, renal outcome