4.6 Article

Major adverse renal events (MARE): a proposal to unify renal endpoints

Journal

NEPHROLOGY DIALYSIS TRANSPLANTATION
Volume 36, Issue 3, Pages 491-497

Publisher

OXFORD UNIV PRESS
DOI: 10.1093/ndt/gfz212

Keywords

composite endpoint; major adverse events; outcome endpoint; renal endpoint; renal outcome

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This study aims to propose standardized renal outcome reporting by introducing major adverse renal events (MARE) as a term for a standardized composite of hard renal outcomes. MARE may include new onset of kidney injury, persistent signs of worsening kidney disease, development of end-stage kidney disease, and death from renal cause. In addition to MARE, patient reported outcomes should also be reported as standard primary endpoints in studies on kidney disease.
Background. In renal studies, various outcome endpoints are used with variable definitions, making it nearly impossible to perform meta-analyses and deduce meaningful conclusions. Increasing attention is directed towards standardization of renal outcome reporting. Methods. A working group was formed to produce a unifying definition of renal outcomes that can be used by all investigators. We propose major adverse renal events (MARE) as the term for a standardized composite of hard renal outcomes. We discuss the components for inclusion in MARE from existing evidence. Results. MARE could include three to five items, considered relevant to patients and regulators. New onset of kidney injury, that is persistent albuminuria/proteinuria and/or decreasing glomerular filtration rate (GFR) <60 ml/min/1.73 m(2), persistent signs of worsening kidney disease, development of end-stage kidney disease with estimated GFR <15 ml/min/1.73 m(2) without or with initiation of kidney replacement therapy, and death from renal cause are core items of MARE. Additionally, patient reported outcomes should be reported in parallel to MARE as a standard set of primary (or secondary) endpoints in studies on kidney disease of diabetic, hypertensive-vascular, or other origin. Conclusions. MARE as a reporting standard will enhance the ability to compare studies and thus, facilitate meaningful meta-analyses. This will result in standardized endpoints that should result in guideline improvement to better individualize care of patients with kidney disease.

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