Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria
NCT ID: NCT03449199
Last Updated: 2022-08-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
130 participants
INTERVENTIONAL
2018-04-10
2019-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TMX-049 40 mg QD (Once Daily)
TMX-049: 40 mg of TMX-049 to be taken orally, once daily
TMX-049
A certain dose of TMX-049 to be taken orally, once daily
TMX-049 200 mg QD (Once Daily)
TMX-049: 200 mg of TMX-049 to be taken orally, once daily
TMX-049
A certain dose of TMX-049 to be taken orally, once daily
TMX-049 Placebo
Placebo
Matching placebo to be taken orally, once daily
Interventions
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TMX-049
A certain dose of TMX-049 to be taken orally, once daily
Placebo
Matching placebo to be taken orally, once daily
Eligibility Criteria
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Inclusion Criteria
* UACR 200 to 3000 mg/g
* eGFR ≥30 ml/min/1.73m2
* Treated with at least the minimal recommended dose of an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB), but not both
Exclusion Criteria
* Women who are breast feeding
* Treatment with any uric acid-lowering therapy within previous 2 weeks
* History of intolerance to any XO (xanthine oxidase) inhibitor
* History of a gout flare requiring pharmacologic treatment
* History or presence of tophaceous gout
* History of immunosuppressant treatment for any known or suspected renal disorder
* History of a non-diabetic form of renal disease
* Glycosylated hemoglobin (HbA1c) \>11%
* sUA \<4.0 mg/dL or \>10.0 mg/dL
* Positive urinary pregnancy test
* Dialysis for acute renal failure within previous 6 months
* Renal allograft in place or a scheduled kidney transplant within the next 22 weeks
* Congenital or acquired solitary kidney
18 Years
ALL
No
Sponsors
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Teijin America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Cressman, D.O.
Role: STUDY_DIRECTOR
Covance
Locations
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AKDHC Medical Research Services, LLC
Flagstaff, Arizona, United States
Aventiv Research Inc.
Mesa, Arizona, United States
Comprehensive Research Institute
Alhambra, California, United States
California Kidney Specialists
Covina, California, United States
Torrance Clinical Research Institute, Inc.
Lomita, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Diabetes Associates Medical Group
Orange, California, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States
California Kidney Specialists
San Dimas, California, United States
North America Research Institute
San Dimas, California, United States
Leon Medical Research
Miami, Florida, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, United States
Endocrine Associates of Florida, P.A.
Ocoee, Florida, United States
Pines Care Research Center
Pembroke Pines, Florida, United States
Hanson Clinical Research Center
Port Charlotte, Florida, United States
Nephrology Associates, PC
Augusta, Georgia, United States
Southeastern Clinical Research Institute
Augusta, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Solaris Clinical Research, Llc
Meridian, Idaho, United States
Associate in Endocrinology
Elgin, Illinois, United States
Community Clinical Research Center
Anderson, Indiana, United States
Community Hospital of Anderson and Madison County, Inc.
Anderson, Indiana, United States
Iowa Kidney Physicians
Des Moines, Iowa, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
My Kidney Center, LLC.
Manhattan, Kansas, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
Four Rivers Clincial Research
Paducah, Kentucky, United States
Ochsner Clinic Foundation, Baton Rouge
Baton Rouge, Louisiana, United States
Biolab Research LLC
Rockville, Maryland, United States
Aa Mrc Llc
Flint, Michigan, United States
Elite Research Center LLC
Flint, Michigan, United States
Endocrine Consultants of Mid Michigan
Flint, Michigan, United States
Seacost Kidney & Hypertension Specialists
Portsmouth, New Hampshire, United States
Albany Medical College, Division of Community Endocinology
Albany, New York, United States
Randolph Health Internal Medicine
Asheboro, North Carolina, United States
Carteret Medical Group
Morehead City, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, United States
Synexus Clinical Research US, Inc. Centennial Health, PC
Oklahoma City, Oklahoma, United States
Detweiler Family Medicine & Associates, PC
Lansdale, Pennsylvania, United States
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, United States
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, United States
Texas Health Physicians Group
Dallas, Texas, United States
The Medical Group of Texas
Fort Worth, Texas, United States
Rockwood Medical Clinic
Fort Worth, Texas, United States
Endocrine Associates
Houston, Texas, United States
Juno Research, LLC
Houston, Texas, United States
The Endocrine Center
Houston, Texas, United States
Pioneer Research Solutions INC
Houston, Texas, United States
Houston Nephrology Research
Houston, Texas, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, United States
BFHC Research
San Antonio, Texas, United States
Carl R. Meisner Medical Clinic, PLLC
Sugar Land, Texas, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TMX-049DN-201
Identifier Type: -
Identifier Source: org_study_id
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