Association of Treatment Effects on Early Change in Urine Protein and Treatment Effects on GFR Slope in IgA Nephropathy: An Individual Participant Meta-analysis.

ABSTRACT:

Rationale & objective

An early change in proteinuria is considered a reasonably likely surrogate end point in immunoglobulin A nephropathy (IgAN) and can be used as a basis for accelerated approval of therapies, with verification in a postmarketing confirmatory trial. Glomerular filtration rate (GFR) slope is a recently validated surrogate end point for chronic kidney disease progression and may be considered as the end point used for verification. We undertook a meta-analysis of clinical trials in IgAN to compare treatment effects on change in proteinuria versus change in estimated GFR (eGFR) slope.

Study design

Individual patient-level meta-analysis.

Setting & study populations

Individual data of 1,037 patients from 12 randomized trials.

Selection criteria for st

SUBMITTER: Inker LA 

PROVIDER: S-EPMC8384669 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature