Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy

Phase 2 Completed 293 enrolled Tanabe Pharma Corporation

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of MT-3995 in subjects with diabetic nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (UACR) in the first morning void urine sample as an indicator.

Timeline

Start: 2015-07
Primary completion: 2016-11
Completion: 2017-01

Outcome

Met primary endpoint

paper placebo: 113.7% at week 24; all P < 0.001 vs placebo PMID 32974732 ↗

Publications

Wada T, Inagaki M, Yoshinari T, Terata R, Totsuka N, Gotou M, Hashimoto G. Apararenone in patients with diabetic nephropathy: results of a randomized, double-blind, placebo-controlled phase 2 dose-response study and open-label extension study. Clin Exp Nephrol. 2021 Feb;25(2):120-130. doi: 10.1007/s10157-020-01963-z. Epub 2020 Sep 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MT-3995	Small molecule	2.5 mg	—
Subject	MT-3995	Small molecule	5 mg	—
Subject	MT-3995	Small molecule	10 mg	—