Study to Evaluate the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease

Summary

The primary objective of this study is to evaluate whether selonsertib (SEL) can slow the decline in kidney function in participants with moderate to advanced diabetic kidney disease (DKD).

Timeline

Start

2019-07-24

Primary completion

2021-09-03

Completion

2021-09-03

Outcome

Missed primary endpoint

registry analysis (superiority test); Randomized SEL 18 mg vs Randomized Placebo; p = 0.1439; Difference in Adjusted Mean 1.20 (95% CI -0.41 to 2.81); Random Slope Model NCT04026165 ↗

Publications

• Heerspink HJL, Perkovic V, Tuttle KR, Pergola PE, Mahaffey KW, Patel UD, Ishida JH, Kuo A, Chen F, Kustra R, Petrovic V, Rossing P, Kashihara N, Chertow GM. Selonsertib in Patients with Diabetic Kidney Disease: A Phase 2b Randomized Active Run-In Clinical Trial. J Am Soc Nephrol. 2024 Dec 1;35(12):1726-1736. doi: 10.1681/ASN.0000000000000444. Epub 2024 Jul 17.

Drugs

Indications