A Study to Evaluate the Soluble Guanylate Cyclase (sGC) Stimulator IW-1973 in Diabetic Nephropathy / Diabetic Kidney Disease as Measured by Albuminuria

Summary

To evaluate the safety and efficacy of IW-1973 in patients with type 2 diabetes mellitus with albuminuria who are on a stable regimen of renin-angiotensin system inhibitors.

Timeline

Start

2017-08-01

Primary completion

2019-08-20

Completion

2019-08-20

Outcome

Missed primary endpoint

paper Praliciguat treatment for 12 weeks did not significantly reduce albuminuria compared with placebo in the primary efficacy analysis. PMID 33328269 ↗

registry analysis (superiority test); Placebo vs Praliciguat Overall; p =0.1736; Geometric mean change (%) -15.3 (90% CI -30.7 to 3.6); Mixed Models Analysis NCT03217591 ↗

Publications

• Hanrahan JP, de Boer IH, Bakris GL, Wilson PJ, Wakefield JD, Seferovic JP, Chickering JG, Chien YT, Carlson K, Cressman MD, Currie MG, Milne GT, Profy AT. Effects of the Soluble Guanylate Cyclase Stimulator Praliciguat in Diabetic Kidney Disease: A Randomized Placebo-Controlled Clinical Trial. Clin J Am Soc Nephrol. 2020 Dec 31;16(1):59-69. doi: 10.2215/CJN.08410520. Epub 2020 Dec 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Praliciguat	Small molecule	20 mg	Oral
Subject	Praliciguat	Small molecule	40 mg	Oral

Indications