Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria
- Registration Number
- NCT03449199
- Lead Sponsor
- Teijin America, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- Type 2 diabetes treated with ≥1 glucose-lowering medication for at least 12 months
- 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
- History of Type 1 diabetes
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TMX-049 Placebo Placebo - TMX-049 200 mg QD (Once Daily) TMX-049 TMX-049: 200 mg of TMX-049 to be taken orally, once daily TMX-049 40 mg QD (Once Daily) TMX-049 TMX-049: 40 mg of TMX-049 to be taken orally, once daily
- Primary Outcome Measures
Name Time Method Changes in Log-transformed Urinary Albumin-to-creatinine Ratio (UACR) at Week 12 Baseline and Week 12 UACR from Baseline to Weeks 2, 6, 12, and 16(Follow-up) were measured. The change from baseline at Week 12 in log-transformed UACR was analyzed and reported as a primary outcome.
- Secondary Outcome Measures
Name Time Method Proportion of Subjects With a Greater Than 30% Reduction From Baseline to Week 12 in Urinary Albumin-to-Creatinine Ratio 16 Weeks Changes in Proportion of Subjects With a Greater Than 30% Reduction From Baseline to Week 12 in Urinary Albumin-to-Creatinine Ratio were measured. Subject with greater than 30% reduction is estimated as responder, less than or equal to 30% reduction is estimated as non-responder.
Changes in Exploratory Blood Biomarkers (Soluble TNF Receptor Type I) 16 Weeks Changes in Exploratory Blood Biomarkers for inflammation (Soluble TNF \[tumor necrosis factor\] Receptor Type I) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Kidney Injury Molecule-1) 16 Weeks Changes in Exploratory Renal Biomarkers for renal tubular diseases (Creatinine-Corrected Kidney Injury Molecule-1) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Changes in Estimated Glomerular Filtration Rate (GFR) Baseline and Week 2, 6, 12, 16 (Follow-up) Estimated Glomerular Filtration Rate from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured. The eGFR (estimated glomerular filtration rate) was calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula based on the serum creatinine measurement.
Changes in Urinary Albumin-to-Creatinine Ratio (UACR) Baseline and Week 2, 6, 12, 16 (Follow-up) Urinary Albumin-to-Creatinine Ratio from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Changes in Exploratory Blood Biomarkers (C Reactive Protein) 16 Weeks Changes in Exploratory Blood Biomarkers for inflammation (C Reactive Protein) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Fatty Acid Binding Protein 1) 16 Weeks Changes in Exploratory Renal Biomarkers for renal tubular diseases (Creatinine-Corrected Fatty Acid Binding Protein 1) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Hydroxy Deoxyguanosine) 16 Weeks Changes in Exploratory Renal Biomarkers for renal tubular diseases (Creatinine-Corrected Hydroxy Deoxyguanosine) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Changes in Serum Uric Acid (sUA) Baseline and Week 2, 6, 12, 16 (Follow-up) Serum Uric Acid from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured in order to explore the sUA (Serum Uric Acid) lowering effect in DKD (diabetic kidney disease) patients and the relationship between sUA and efficacy to DKD.
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase) 16 Weeks Changes in Exploratory Renal Biomarkers for renal tubular diseases (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Trial Locations
- Locations (54)
Aventiv Research Inc.
🇺🇸Mesa, Arizona, United States
Comprehensive Research Institute
🇺🇸Alhambra, California, United States
California Kidney Specialists
🇺🇸San Dimas, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Torrance Clinical Research Institute, Inc.
🇺🇸Lomita, California, United States
Desert Oasis Healthcare Medical Group
🇺🇸Palm Springs, California, United States
Diabetes Associates Medical Group
🇺🇸Orange, California, United States
North America Research Institute
🇺🇸San Dimas, California, United States
San Marcus Research Clinic, Inc.
🇺🇸Miami Lakes, Florida, United States
Nephrology Associates, PC
🇺🇸Augusta, Georgia, United States
Hanson Clinical Research Center
🇺🇸Port Charlotte, Florida, United States
Southeastern Clinical Research Institute
🇺🇸Augusta, Georgia, 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
Four Rivers Clincial Research
🇺🇸Paducah, Kentucky, United States
Elite Research Center LLC
🇺🇸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
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
Carl R. Meisner Medical Clinic, PLLC
🇺🇸Sugar Land, Texas, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, 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
Leon Medical Research
🇺🇸Miami, Florida, United States
Clinical Advancement Center, PLLC
🇺🇸San Antonio, Texas, United States
BFHC Research
🇺🇸San Antonio, Texas, United States
Cotton O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
My Kidney Center, LLC.
🇺🇸Manhattan, Kansas, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Synexus Clinical Research US, Inc. Centennial Health, PC
🇺🇸Oklahoma City, Oklahoma, United States
Biolab Research LLC
🇺🇸Rockville, Maryland, United States
Pines Care Research Center
🇺🇸Pembroke Pines, Florida, United States
AKDHC Medical Research Services, LLC
🇺🇸Flagstaff, Arizona, United States
Ochsner Clinic Foundation, Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Endocrine Associates of Florida, P.A.
🇺🇸Ocoee, Florida, United States
Aa Mrc Llc
🇺🇸Flint, Michigan, United States
Solaris Clinical Research, Llc
🇺🇸Meridian, Idaho, United States
Endocrine Consultants of Mid Michigan
🇺🇸Flint, Michigan, United States
University of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States