Atrasentan in Patients With IgA Nephropathy

Summary

The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function.

Timeline

Start

2020-12-11

Primary completion

2028-04-14

Completion

2028-04-14

Outcome

Met primary endpoint

paper In this prespecified interim analysis, atrasentan resulted in a significant and clinically meaningful reduction in proteinuria as compared with placebo in patients with IgA nephropathy. PMID 39460694 ↗

release “Phase III ALIGN study met its primary endpoint” novartis.com ↗

Publications

• Heerspink HJL, Jardine MJ, Kohan DE, Lafayette R, Levin A, Liew A, Zhang H, Noronha IL, Mastroianni-Kirsztajn G, Chow S, Choi DE, Lv J, Trimarchi H, Fu P, Guenther S, Yang S, Liu J, Rahalkar S, Lodha A, Dahlke M, Kollins D, Barratt J; ALIGN study group. Atrasentan in patients with IgA nephropathy (ALIGN): final 2.5-year results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2026 Jun 13;407(10546):2387-2401. doi: 10.1016/S0140-6736(26)00960-8. Epub 2026 Jun 4.
• Kuo JJ, Wu J, Gunawan MG, McConnell MT, Lester J, Naidu NA, Nieh CH, Surendradoss J, Kano T, Suzuki Y, Olson NE, Cox JH. Effects of Atrasentan on Kidney Gene Transcription, Mesangial Cell Proliferation, and Proteinuria in IgA Nephropathy. Kidney360. 2026 May 1;7(5):1003-1016. doi: 10.34067/KID.0000001000. Epub 2025 Dec 24.
• Heerspink HJL, Jardine M, Kohan DE, Lafayette RA, Levin A, Liew A, Zhang H, Lodha A, Gray T, Wang Y, Renfurm R, Barratt J; ALIGN Study Investigators. Atrasentan in Patients with IgA Nephropathy. N Engl J Med. 2025 Feb 6;392(6):544-554. doi: 10.1056/NEJMoa2409415. Epub 2024 Oct 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atrasentan	Other / unclassified	0.75 mg	Oral
Subject	zigakibart	Monoclonal antibody	—	—

Indications