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Defining a minimal clinically meaningful difference in 12‐month estimated glomerular filtration rate for clinical trials in deceased donor kidney transplantation
Author(s) -
Mayne Tracy J.,
Nordyke Robert J.,
Schold Jesse D.,
Weir Matthew R.,
Mohan Sumit
Publication year - 2021
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/ctr.14326
Subject(s) - medicine , hazard ratio , renal function , observational study , clinical trial , kidney transplantation , population , urology , transplantation , proportional hazards model , kidney disease , oncology , surgery , confidence interval , environmental health
Abstract Background A Minimal Clinically Meaningful Difference (MCMD) has not been defined for Estimated glomerular filtration rate (eGFR). Our goal was to define the MCMD for eGFR anchored to kidney graft failure. Methods A systematic review of studies with 12‐month eGFR and subsequent renal graft failure was conducted. For observational studies, we calculated hazard ratio (HR) differences between adjacent eGFR intervals weighted by population distribution. Interventional trials yielded therapeutically induced changes in eGFR and failure risk. OPTN data analysis divided 12‐month eGFR into bands for Cox regressions comparing adjacent eGFR bands with a death‐censored graft survival outcome. Results Observational studies indicated that lower eGFR was associated with increased death‐censored graft failure risk; each 5 ml/min/1.73 m 2 12‐month eGFR band associated with a weighted incremental HR = 1.12 to 1.23. Clinical trial data found a 5 ml/min/1.73 m 2 difference was associated with incremental HR = 1.16 to 1.35. OPTN analyses showed weighted mean HRs across 10, 7, and 5 ml/min/1.73 m 2 bands of 1.47, 1.30, and 1.19. Conclusions A 5 ml/min/1.73 m 2 difference in 12‐month eGFR was consistently associated with ~20% increase in death‐censored graft failure risk. The magnitude of effect has been interpreted as clinically meaningful in other disease states and should be considered the MCMD in renal transplantation clinical trials.

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