CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 130 enrolled
Drug / intervention
TMX-049 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03449199
NCT03449199Phase 2Completed
CompareCT.gov

A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess Safety, Tolerability, and Renal Effects of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria

Teijin America, Inc.·interventional·Posted Feb 28, 2018·Updated Aug 30, 2022

In Brief

A Phase 2 clinical trial evaluating TMX-049 and Placebo for Diabetic Kidney Disease. Completed, enrolled 130 participants across 55 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Kidney Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedFeb 28, 2018
Enrollment StartApr 10, 2018
Primary CompletionMay 7, 2019
Study CompletionJun 4, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.3 years ago

Interventions

TMX-049drug

A certain dose of TMX-049 to be taken orally, once daily

Placebodrug

Matching placebo to be taken orally, once daily