GFR Slope as a Surrogate End Point for Kidney Disease Progression in Clinical Trials: A Meta-Analysis of Treatment Effects of Randomized Controlled Trials

Surrogate end points are needed to assess whether treatments are effective in the early stages of CKD. GFR decline leads to kidney failure, but regulators have not approved using differences in the change in GFR from the beginning to the end of a randomized, controlled trial as an end point in CKD b...

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Veröffentlicht in:	Journal of the American Society of Nephrology Jg. 30; H. 9; S. 1735
Hauptverfasser:	Inker, Lesley A, Heerspink, Hiddo J L, Tighiouart, Hocine, Levey, Andrew S, Coresh, Josef, Gansevoort, Ron T, Simon, Andrew L, Ying, Jian, Beck, Gerald J, Wanner, Christoph, Floege, Jürgen, Li, Philip Kam-Tao, Perkovic, Vlado, Vonesh, Edward F, Greene, Tom
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	United States 01.09.2019
Schlagworte:	Bayes Theorem Biomarkers Creatinine - blood Disease Progression Glomerular Filtration Rate Humans Kidney Failure, Chronic - etiology Kidney Failure, Chronic - physiopathology Predictive Value of Tests Randomized Controlled Trials as Topic Renal Insufficiency, Chronic - complications Renal Insufficiency, Chronic - physiopathology Renal Insufficiency, Chronic - therapy meta-analysis GFR chronic kidney disease end stage kidney disease randomized controlled trials
ISSN:	1533-3450, 1533-3450
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Abstract	Surrogate end points are needed to assess whether treatments are effective in the early stages of CKD. GFR decline leads to kidney failure, but regulators have not approved using differences in the change in GFR from the beginning to the end of a randomized, controlled trial as an end point in CKD because it is not clear whether small changes in the GFR slope will translate to clinical benefits. To assess the use of GFR slope as a surrogate end point for CKD progression, we performed a meta-analysis of 47 RCTs that tested 12 interventions in 60,620 subjects. We estimated treatment effects on GFR slope (mean difference in GFR slope between the randomized groups), for the total slope starting at baseline, chronic slope starting at 3 months after randomization, and on the clinical end point (doubling of serum creatinine, GFR<15 ml/min per 1.73 m , or ESKD) for each study. We used Bayesian mixed-effects analyses to describe the association of treatment effects on GFR slope with the clinical end point and to test how well the GFR slope predicts a treatment's effect on the clinical end point. Across all studies, the treatment effect on 3-year total GFR slope (median =0.97; 95% Bayesian credible interval [BCI], 0.78 to 1.00) and on the chronic slope ( 0.96; 95% BCI, 0.63 to 1.00) accurately predicted treatment effects on the clinical end point. With a sufficient sample size, a treatment effect of 0.75 ml/min per 1.73 m /yr or greater on total slope over 3 years or chronic slope predicts a clinical benefit on CKD progress with at least 96% probability. With large enough sample sizes, GFR slope may be a viable surrogate for clinical end points in CKD RCTs.
AbstractList	Surrogate end points are needed to assess whether treatments are effective in the early stages of CKD. GFR decline leads to kidney failure, but regulators have not approved using differences in the change in GFR from the beginning to the end of a randomized, controlled trial as an end point in CKD because it is not clear whether small changes in the GFR slope will translate to clinical benefits.BACKGROUNDSurrogate end points are needed to assess whether treatments are effective in the early stages of CKD. GFR decline leads to kidney failure, but regulators have not approved using differences in the change in GFR from the beginning to the end of a randomized, controlled trial as an end point in CKD because it is not clear whether small changes in the GFR slope will translate to clinical benefits.To assess the use of GFR slope as a surrogate end point for CKD progression, we performed a meta-analysis of 47 RCTs that tested 12 interventions in 60,620 subjects. We estimated treatment effects on GFR slope (mean difference in GFR slope between the randomized groups), for the total slope starting at baseline, chronic slope starting at 3 months after randomization, and on the clinical end point (doubling of serum creatinine, GFR<15 ml/min per 1.73 m2, or ESKD) for each study. We used Bayesian mixed-effects analyses to describe the association of treatment effects on GFR slope with the clinical end point and to test how well the GFR slope predicts a treatment's effect on the clinical end point.METHODSTo assess the use of GFR slope as a surrogate end point for CKD progression, we performed a meta-analysis of 47 RCTs that tested 12 interventions in 60,620 subjects. We estimated treatment effects on GFR slope (mean difference in GFR slope between the randomized groups), for the total slope starting at baseline, chronic slope starting at 3 months after randomization, and on the clinical end point (doubling of serum creatinine, GFR<15 ml/min per 1.73 m2, or ESKD) for each study. We used Bayesian mixed-effects analyses to describe the association of treatment effects on GFR slope with the clinical end point and to test how well the GFR slope predicts a treatment's effect on the clinical end point.Across all studies, the treatment effect on 3-year total GFR slope (median R2=0.97; 95% Bayesian credible interval [BCI], 0.78 to 1.00) and on the chronic slope (R2 0.96; 95% BCI, 0.63 to 1.00) accurately predicted treatment effects on the clinical end point. With a sufficient sample size, a treatment effect of 0.75 ml/min per 1.73 m2/yr or greater on total slope over 3 years or chronic slope predicts a clinical benefit on CKD progress with at least 96% probability.RESULTSAcross all studies, the treatment effect on 3-year total GFR slope (median R2=0.97; 95% Bayesian credible interval [BCI], 0.78 to 1.00) and on the chronic slope (R2 0.96; 95% BCI, 0.63 to 1.00) accurately predicted treatment effects on the clinical end point. With a sufficient sample size, a treatment effect of 0.75 ml/min per 1.73 m2/yr or greater on total slope over 3 years or chronic slope predicts a clinical benefit on CKD progress with at least 96% probability.With large enough sample sizes, GFR slope may be a viable surrogate for clinical end points in CKD RCTs.CONCLUSIONSWith large enough sample sizes, GFR slope may be a viable surrogate for clinical end points in CKD RCTs. Surrogate end points are needed to assess whether treatments are effective in the early stages of CKD. GFR decline leads to kidney failure, but regulators have not approved using differences in the change in GFR from the beginning to the end of a randomized, controlled trial as an end point in CKD because it is not clear whether small changes in the GFR slope will translate to clinical benefits. To assess the use of GFR slope as a surrogate end point for CKD progression, we performed a meta-analysis of 47 RCTs that tested 12 interventions in 60,620 subjects. We estimated treatment effects on GFR slope (mean difference in GFR slope between the randomized groups), for the total slope starting at baseline, chronic slope starting at 3 months after randomization, and on the clinical end point (doubling of serum creatinine, GFR<15 ml/min per 1.73 m , or ESKD) for each study. We used Bayesian mixed-effects analyses to describe the association of treatment effects on GFR slope with the clinical end point and to test how well the GFR slope predicts a treatment's effect on the clinical end point. Across all studies, the treatment effect on 3-year total GFR slope (median =0.97; 95% Bayesian credible interval [BCI], 0.78 to 1.00) and on the chronic slope ( 0.96; 95% BCI, 0.63 to 1.00) accurately predicted treatment effects on the clinical end point. With a sufficient sample size, a treatment effect of 0.75 ml/min per 1.73 m /yr or greater on total slope over 3 years or chronic slope predicts a clinical benefit on CKD progress with at least 96% probability. With large enough sample sizes, GFR slope may be a viable surrogate for clinical end points in CKD RCTs.
Author	Wanner, Christoph Heerspink, Hiddo J L Perkovic, Vlado Inker, Lesley A Greene, Tom Coresh, Josef Simon, Andrew L Ying, Jian Floege, Jürgen Tighiouart, Hocine Vonesh, Edward F Gansevoort, Ron T Levey, Andrew S Li, Philip Kam-Tao Beck, Gerald J
Author_xml	– sequence: 1 givenname: Lesley A surname: Inker fullname: Inker, Lesley A email: LInker@tuftsmedicalcenter.org organization: Division of Nephrology and LInker@tuftsmedicalcenter.org – sequence: 2 givenname: Hiddo J L surname: Heerspink fullname: Heerspink, Hiddo J L organization: Departments of Clinical Pharmacy and Pharmacology and – sequence: 3 givenname: Hocine surname: Tighiouart fullname: Tighiouart, Hocine organization: Tufts Clinical and Translational Science Institute, Tufts University, Boston, Massachusetts – sequence: 4 givenname: Andrew S surname: Levey fullname: Levey, Andrew S organization: Division of Nephrology and – sequence: 5 givenname: Josef surname: Coresh fullname: Coresh, Josef organization: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland – sequence: 6 givenname: Ron T surname: Gansevoort fullname: Gansevoort, Ron T organization: Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands – sequence: 7 givenname: Andrew L surname: Simon fullname: Simon, Andrew L organization: Division of Nephrology and – sequence: 8 givenname: Jian surname: Ying fullname: Ying, Jian organization: Division of Epidemiology, Department of Internal Medicine, University of Utah, Salt Lake City, Utah – sequence: 9 givenname: Gerald J surname: Beck fullname: Beck, Gerald J organization: Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio – sequence: 10 givenname: Christoph surname: Wanner fullname: Wanner, Christoph organization: Division of Nephrology, University Hospital of Würzburg, Würzburg, Germany – sequence: 11 givenname: Jürgen surname: Floege fullname: Floege, Jürgen organization: Division of Nephrology, RWTH Aachen University, Aachen, Germany – sequence: 12 givenname: Philip Kam-Tao surname: Li fullname: Li, Philip Kam-Tao email: LInker@tuftsmedicalcenter.org organization: Division of Nephrology, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, Hong Kong; LInker@tuftsmedicalcenter.org – sequence: 13 givenname: Vlado surname: Perkovic fullname: Perkovic, Vlado organization: George Institute for Global Health, University of New South Wales, Sydney, Australia; and – sequence: 14 givenname: Edward F surname: Vonesh fullname: Vonesh, Edward F organization: Department of Preventive Medicine, Division of Biostatistics, Northwestern University, Chicago, Illinois – sequence: 15 givenname: Tom surname: Greene fullname: Greene, Tom organization: Division of Epidemiology, Department of Internal Medicine, University of Utah, Salt Lake City, Utah
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Snippet	Surrogate end points are needed to assess whether treatments are effective in the early stages of CKD. GFR decline leads to kidney failure, but regulators have...
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SubjectTerms	Bayes Theorem Biomarkers Creatinine - blood Disease Progression Glomerular Filtration Rate Humans Kidney Failure, Chronic - etiology Kidney Failure, Chronic - physiopathology Predictive Value of Tests Randomized Controlled Trials as Topic Renal Insufficiency, Chronic - complications Renal Insufficiency, Chronic - physiopathology Renal Insufficiency, Chronic - therapy
Title	GFR Slope as a Surrogate End Point for Kidney Disease Progression in Clinical Trials: A Meta-Analysis of Treatment Effects of Randomized Controlled Trials
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