Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy

Summary

The ASSIST study was a phase 2, double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of atrasentan vs. placebo in subjects with IgA nephropathy (IgAN) while on background standard of care therapy and an SGLT2 inhibitor (SGLT2i).

Timeline

Start

2023-07-20

Primary completion

2025-06-30

Completion

2025-10-29

Outcome

Met primary endpoint

registry analysis (superiority test); Atrasentan vs Placebo; p = 0.0006; % Mean treatment difference -25.3 (95% CI -36.8 to -11.7) NCT05834738 ↗

Publications

• Heerspink HJL, Noronha IL, Gorriz JL, Lim SK, Kotwal SS, Kirsztajn GM, Barros Neto J, Ryan J, Fu MS, Kim SG, Barratt J, Brahmbhatt Y, Housler GJ, Jiao R, Dahlke M, Lodha A, Mottl AK; Atrasentan and Sodium Glucose Cotransporter-2 Inhibitor Efficacy and Safety Trial (ASSIST) Investigator Group. Efficacy and Safety of Atrasentan in Patients with IgA Nephropathy Receiving Sodium-Glucose Cotransporter 2 Inhibitors: Placebo-Controlled, Crossover Trial. J Am Soc Nephrol. 2026 Mar 29. doi: 10.1681/ASN.0000001076. Online ahead of print.
• Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

Drugs

Indications