Atrasentan in patients with IgA nephropathy (ALIGN): final 2·5-year results from a randomised, double-blind, placebo-controlled, phase 3 trial.
Publication/Presentation Date
6-13-2026
Abstract
BACKGROUND: Atrasentan, a selective endothelin A receptor antagonist, reduced proteinuria in the prespecified interim analysis (week 36) of the ALIGN trial in adults with IgA nephropathy. We assessed whether atrasentan slowed estimated glomerular filtration rate (eGFR) decline after 2·5 years' treatment.
METHODS: We performed a randomised, double-blind, placebo-controlled, phase 3 trial (133 sites, 20 countries). Adults with biopsy-proven IgA nephropathy, eGFR of at least 30 mL/min per 1·73 m
FINDINGS: Between March 15, 2021, and April 28, 2023, 404 participants were randomly assigned (main stratum: 340; SGLT2 inhibitor stratum: 64). In the main stratum, change from baseline in eGFR at week 136 was -7·5 mL/min per 1·73 m
INTERPRETATION: Atrasentan reduced proteinuria and preserved kidney function after 2·5 years. This effect was present with or without concomitant SGLT2 inhibitor use. Atrasentan was well tolerated.
FUNDING: Novartis.
Volume
407
Issue
10546
First Page
2387
Last Page
2401
ISSN
1474-547X
Published In/Presented At
Heerspink, H. J. L., Jardine, M. J., Kohan, D. E., Lafayette, R., Levin, A., Liew, A., Zhang, H., Noronha, I. L., Mastroianni-Kirsztajn, G., Chow, S., Choi, D. E., Lv, J., Trimarchi, H., Fu, P., Guenther, S., Yang, S., Liu, J., Rahalkar, S., Lodha, A., Dahlke, M., … ALIGN study group (2026). Atrasentan in patients with IgA nephropathy (ALIGN): final 2·5-year results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet (London, England), 407(10546), 2387–2401. https://doi.org/10.1016/S0140-6736(26)00960-8
Disciplines
Medicine and Health Sciences
PubMedID
42242268
Department(s)
Department of Medicine
Document Type
Article