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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT03449199

Public ClinicalTrials.gov record NCT03449199. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 6:01 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03449199
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Teijin America, Inc.
Industry
Enrollment
130 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 10, 2018 (Actual)
Primary completion
May 7, 2019 (Actual)
Completion
Jun 4, 2019 (Actual)
Last update posted
Aug 30, 2022

2018 – 2019

United States locations

U.S. sites
55
U.S. states
23
U.S. cities
44
Facility City State ZIP Site status
AKDHC Medical Research Services, LLC Flagstaff Arizona 86001 —
Aventiv Research Inc. Mesa Arizona 85210 —
Comprehensive Research Institute Alhambra California 91801 —
California Kidney Specialists Covina California 91723 —
Torrance Clinical Research Institute, Inc. Lomita California 90717 —
Valley Clinical Trials, Inc. Northridge California 91325 —
Diabetes Associates Medical Group Orange California 92868 —
Desert Oasis Healthcare Medical Group Palm Springs California 92262 —
California Kidney Specialists San Dimas California 91773 —
North America Research Institute San Dimas California 91773 —
Leon Medical Research Miami Florida 33015 —
San Marcus Research Clinic, Inc. Miami Lakes Florida 33014 —
Endocrine Associates of Florida, P.A. Ocoee Florida 34761 —
Pines Care Research Center Pembroke Pines Florida 33026 —
Hanson Clinical Research Center Port Charlotte Florida 33952 —
Nephrology Associates, PC Augusta Georgia 30901 —
Southeastern Clinical Research Institute Augusta Georgia 30909 —
East-West Medical Research Institute Honolulu Hawaii 96814 —
Solaris Clinical Research, Llc Meridian Idaho 83646 —
Associate in Endocrinology Elgin Illinois 60124 —
Community Clinical Research Center Anderson Indiana 46011 —
Community Hospital of Anderson and Madison County, Inc. Anderson Indiana 46011 —
Iowa Kidney Physicians Des Moines Iowa 50265 —
Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa 50265 —
My Kidney Center, LLC. Manhattan Kansas 66502 —
Cotton O'Neil Clinical Research Center Topeka Kansas 66606 —
Four Rivers Clincial Research Paducah Kentucky 42003 —
Ochsner Clinic Foundation, Baton Rouge Baton Rouge Louisiana 70809 —
Biolab Research LLC Rockville Maryland 20852 —
Aa Mrc Llc Flint Michigan 48504 —
Elite Research Center LLC Flint Michigan 48532 —
Endocrine Consultants of Mid Michigan Flint Michigan 48532 —
Seacost Kidney & Hypertension Specialists Portsmouth New Hampshire 03801 —
Albany Medical College, Division of Community Endocinology Albany New York 12206 —
Randolph Health Internal Medicine Asheboro North Carolina 27203 —
Carteret Medical Group Morehead City North Carolina 28557 —
PMG Research of Wilmington, LLC Wilmington North Carolina 28401 —
Brookview Hills Research Associates, LLC Winston-Salem North Carolina 27103 —
Synexus Clinical Research US, Inc. Centennial Health, PC Oklahoma City Oklahoma 73111 —
Detweiler Family Medicine & Associates, PC Lansdale Pennsylvania 19446 —
University Diabetes & Endocrine Consultants Chattanooga Tennessee 37411 —
Knoxville Kidney Center, PLLC Knoxville Tennessee 37923 —
Texas Health Physicians Group Dallas Texas 75243 —
The Medical Group of Texas Fort Worth Texas 76116 —
Rockwood Medical Clinic Fort Worth Texas 76164 —
Endocrine Associates Houston Texas 77004 —
Juno Research, LLC Houston Texas 77040 —
The Endocrine Center Houston Texas 77079 —
Pioneer Research Solutions INC Houston Texas 77099 —
Houston Nephrology Research Houston Texas 77429 —
Clinical Advancement Center, PLLC San Antonio Texas 78212 —
BFHC Research San Antonio Texas 78249 —
Carl R. Meisner Medical Clinic, PLLC Sugar Land Texas 77478 —
University of Utah School of Medicine Salt Lake City Utah 84108 —
Manassas Clinical Research Center Manassas Virginia 20110 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03449199, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 30, 2022 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03449199 live on ClinicalTrials.gov.

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