Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria
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.
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
- Enrollment
- 130 participants
Conditions and interventions
Conditions
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 9, 2018
- Primary completion
- May 6, 2019
- Completion
- Jun 3, 2019
- Last update posted
- Aug 29, 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 29, 2022 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03449199 live on ClinicalTrials.gov.