Contribution of the glomerular filtration rate slope to the kidney hierarchical composite endpoint

被引：1

作者：

Little, Dustin J. ^{[1
]}

Jongs, Niels ^{[2
]}

Brinker, Meike ^{[3
]}

Gasparyan, Samvel B. ^{[4
]}

Schloemer, Patrick ^{[5
]}

Heerspink, Hiddo J. L. ^{[2
,6
]}

机构：

[1] AstraZeneca, Late Stage Dev Cardiovasc Renal & Metab CVRM, Biopharmaceut R&D, Gaithersburg, MD USA

[2] Univ Groningen, Univ Med Ctr Groningen, Dept Clin Pharm & Pharmacol, Groningen, Netherlands

[3] Bayer AG, Pharmaceut Res & Dev, Berlin, Germany

[4] AstraZeneca, Late Stage Dev Cardiovasc Renal & Metab CVRM, BioPharmaceut R&D, Boston, MA USA

[5] Bayer AG, Pharmaceut Res & Dev, Wuppertal, Germany

[6] George Inst Global Hlth, Sydney, NSW, Australia

来源：

KIDNEY INTERNATIONAL | 2025年 / 107卷 / 06期

关键词：

chronic kidney disease; clinical trial design; glomerular filtration rate; hierarchical composite endpoint;

D O I：

10.1016/j.kint.2025.03.011

中图分类号：

R5 [内科学]; R69 [泌尿科学（泌尿生殖系疾病）];

学科分类号：

1002 ; 100201 ;

摘要：

Introduction: A recent chronic kidney disease (CKD) progression hierarchical composite endpoint (HCE) utilizes the glomerular filtration rate (GFR) slope for participants without a dichotomous event. Here, we evaluated clinical interpretations when HCE analyses are driven by GFR slope comparisons. Methods: Using CKD trial data, we calculated win odds using only GFR slope; dichotomous kidney events and GFR slope; all-cause mortality, dichotomous kidney events, and GFR slope; and all-cause mortality with dichotomous kidney events. Results: Win odds (95% confidence interval) calculated from pairwise GFR slope only comparisons were 1.44 (1.34-1.55), 1.60 (1.49-1.72), 1.19 (1.10-1.28), and 0.82 (0.78-0.86) in the DAPA-CKD, CREDENCE, SONAR, and ALTITUDE trials, respectively. Win odds were similar for the GFR slope only and full kidney HCE with and without mortality. Conclusions: These results support incorporation of GFR slope into the CKD progression HCE and help to interpret the magnitude of treatment effect on kidney HCE estimated with win odds.

引用

页码：1104 / 1107

页数：4

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