Early Change in Proteinuria as a Surrogate Endpoint in Studies of IgA Nephropathy: An Updated Patient-Level Meta-analysis and Discussion of Appropriate Methodology.

ABSTRACT:

Introduction

Immunoglobulin A (IgA) nephropathy is a rare renal condition associated with a high risk of kidney failure. However, conducting phase 3 clinical trials with kidney failure as a primary endpoint is generally not feasible because of sample size and protracted follow-up requirements. Hence, surrogate outcomes are necessary when assessing new treatments in randomized controlled trials. Previous meta-analyses have assessed the validity of early change in proteinuria as a surrogate endpoint, and the present research updates the analysis with additional patient-level data.

Methods

The same methodology as two previously published individual patient-level meta-analyses was used, with additional data from the PROTECT study included. Early change in proteinuria was defined

SUBMITTER: Maillard N 

PROVIDER: S-EPMC12858593 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature