Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria

Phase 2 Completed 130 enrolled Teijin America, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to assess the effect of 2 dose levels of TMX-049 on urinary albumin excretion in subjects with Type 2 diabetes and albuminuria (a urinary albumin-to-creatinine ratio (UACR) 200 to 3000 mg/g and an estimated glomerular filtration rate (eGFR) ≥30 ml/min/1.73m2). Effects of each TMX-049 dose on UACR will be assessed in terms of ratios using log-transformed UACR at Baseline and after a 12-week period of treatment.

Timeline

Start: 2018-04-10
Primary completion: 2019-05-07
Completion: 2019-06-04

Outcome

Met primary endpoint

registry TMX-049 Placebo vs TMX-049 200 mg QD; p = 0.0311; LS Mean Difference -0.43 (95% CI -0.82 to -0.04); ANCOVA NCT03449199 ↗

release “第Ⅱ相臨床試験（TMX-049DN-201試験）の有効性に関する主要評価項目を達成しました。” teijin-pharma.co.jp ↗

Publications

Bakris GL, Mikami H, Hirata M, Nakajima A, Cressman MD. A Non-purine Xanthine Oxidoreductase Inhibitor Reduces Albuminuria in Patients with DKD: A Randomized Controlled Trial. Kidney360. 2021 Jun 30;2(8):1240-1250. doi: 10.34067/KID.0001672021. eCollection 2021 Aug 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TMX-049	Unknown	40 mg	Oral
Subject	TMX-049	Unknown	200 mg	Oral