Study Design and Baseline Characteristics of ALIGN, a Randomized Controlled Study of Atrasentan in Patients With IgA Nephropathy.

ABSTRACT:

Introduction

Endothelin A (ETA) receptor activation is a driver of proteinuria, kidney inflammation, and fibrosis in IgA nephropathy (IgAN). Atrasentan, a selective ETA receptor antagonist, has potential to reduce proteinuria and preserve kidney function in IgAN. ALIGN (NCT04573478) is a phase 3, randomized, double-blind, placebo-controlled clinical trial of atrasentan in patients with IgAN at high risk of kidney function loss.

Methods

Eligibility criteria for the ALIGN main stratum included patients with biopsy-proven IgAN, total protein excretion ≥ 1 g/d, estimated glomerular filtration rate (eGFR) ≥ 30 ml/min per 1.73 m², receiving a maximally tolerated stable dose of a renin-angiotensin system (RAS) inhibitor. An exploratory stratum enrolled participants also

SUBMITTER: Heerspink HJL 

PROVIDER: S-EPMC11725817 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature