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

NCT03449199 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2022-08-30

Study results available
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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.

Conditions

  • Diabetic Kidney Disease

Interventions

DRUG

TMX-049

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

DRUG

Placebo

Matching placebo to be taken orally, once daily

Sponsors & Collaborators

  • Teijin America, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Cressman, D.O. · Covance

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-10
Primary Completion
2019-05-07
Completion
2019-06-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03449199 on ClinicalTrials.gov