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

Abstract

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 m2, persistent signs of worsening kidney disease, development of end-stage kidney disease with estimated GFR <15 ml/min/1.73 m2 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.

Clonal Hematopoiesis of Indeterminate Potential and Diabetic Kidney Disease: A Nested Case-Control Study

“…Initiation of kidney replacement therapy (dialysis or transplantation) and death from kidney failure were investigator-reported. The components of the composite end point were selected on the basis of the proposed definition of major adverse renal events 30 and the international consensus definition of clinical trial outcomes for kidney failure. 31 Of 1419 eligible PROVALID participants (selection cohort), 64 patients were identified who reached the composite end point within the observation period (cases).…”

Short- and long-term outcomes of intensive care patients with acute kidney disease

“…Major adverse kidney outcomes (MAKEs) were defined as a drop in at least 30% in eGFR from baseline, doubling in serum creatinine and initiation of long-term KRT. 15 , 16 The final point of collection for all data was 31st March 2020. To identify rates of new CKD stage 3A or worse, patients with a pre-admission eGFR value of > 60 ml/min/1.73m 2 were identified to exclude patients with pre-existing CKD based on eGFR criteria.…”

Multimorbidity and the risk of major adverse kidney events: findings from the UK Biobank cohort

“…The primary outcome was MAKE [ 25 ]: the first of the following endpoints to occur: the need to receive long-term KRT, doubling of serum creatinine, fall of eGFR to <15 mL/min/1.73 m 2 or 30% decline in eGFR from baseline. This definition is based on previous work from the Chronic Kidney Disease Prognosis Consortium [ 26 , 27 ].…”