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Evaluation of Variation in the Performance of GFR Slope as a Surrogate End Point for Kidney Failure in Clinical Trials that Differ by Severity of CKD.
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- Author(s): Collier W;Collier W;Collier W; Inker LA; Inker LA; Haaland B; Haaland B; Appel GB; Appel GB; Badve SV; Badve SV; Caravaca-Fontán F; Caravaca-Fontán F; Chalmers J; Chalmers J; Floege J; Floege J; Goicoechea M; Goicoechea M; Imai E; Imai E; Jafar TH; Jafar TH; Lewis JB; Lewis JB; Li PKT; Li PKT; Locatelli F; Locatelli F; Maes BD; Maes BD; Neuen BL; Neuen BL; Perrone RD; Perrone RD; Remuzzi G; Remuzzi G; Schena FP; Schena FP; Wanner C; Wanner C; Heerspink HJL; Heerspink HJL; Greene T; Greene T
- Source:
Clinical journal of the American Society of Nephrology : CJASN [Clin J Am Soc Nephrol] 2023 Feb 01; Vol. 18 (2), pp. 183-192. Date of Electronic Publication: 2023 Jan 19.- Publication Type:
Journal Article; Research Support, N.I.H., Extramural- Language:
English - Source:
- Additional Information
- Corporate Authors:
- Source: Publisher: Wolters Kluwer Health Country of Publication: United States NLM ID: 101271570 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1555-905X (Electronic) Linking ISSN: 15559041 NLM ISO Abbreviation: Clin J Am Soc Nephrol Subsets: MEDLINE
- Publication Information: Publication: 2023- : Hagerstown, MD : Wolters Kluwer Health
Original Publication: Washington, D.C. : American Society of Nephrology, c2005- - Subject Terms:
- Abstract: Background: The GFR slope has been evaluated as a surrogate end point for kidney failure in meta-analyses on a broad collection of randomized controlled trials (RCTs) in CKD. These analyses evaluate how accurately a treatment effect on GFR slope predicts a treatment effect on kidney failure. We sought to determine whether severity of CKD in the patient population modifies the performance of GFR slope.
Methods: We performed Bayesian meta-regression analyses on 66 CKD RCTs to evaluate associations between effects on GFR slope (the chronic slope and the total slope over 3 years, expressed as mean differences in ml/min per 1.73 m2/yr) and those of the clinical end point (doubling of serum creatinine, GFR <15 ml/min per 1.73 m2, or kidney failure, expressed as a log-hazard ratio), where models allow interaction with variables defining disease severity. We evaluated three measures (baseline GFR in 10 ml/min per 1.73 m2, baseline urine albumin-to-creatinine ratio [UACR] per doubling in mg/g, and CKD progression rate defined as the control arm chronic slope, in ml/min per 1.73 m2/yr) and defined strong evidence for modification when 95% posterior credible intervals for interaction terms excluded zero.
Results: There was no evidence for modification by disease severity when evaluating 3-year total slope (95% credible intervals for the interaction slope: baseline GFR [-0.05 to 0.03]; baseline UACR [-0.02 to 0.04]; CKD progression rate [-0.07 to 0.02]). There was strong evidence for modification in evaluations of chronic slope (95% credible intervals: baseline GFR [0.02 to 0.11]; baseline UACR [-0.11 to -0.02]; CKD progression rate [0.01 to 0.15]).
Conclusions: These analyses indicate consistency of the performance of total slope over 3 years, which provides further evidence for its validity as a surrogate end point in RCTs representing varied CKD populations.
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- Accession Number: 0 (Biomarkers)
- Publication Date: Date Created: 20230208 Date Completed: 20230210 Latest Revision: 20240306
- Publication Date: 20240306
- Accession Number: PMC10103374
- Accession Number: 10.2215/CJN.0000000000000050
- Accession Number: 36754007
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