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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
130
Changes in Log-transformed Urinary Albumin-to-creatinine Ratio (UACR) at 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.
Time frame: Baseline and Week 12
Changes in Estimated Glomerular Filtration Rate (GFR)
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.
Time frame: Baseline and Week 2, 6, 12, 16 (Follow-up)
Changes in Serum Uric Acid (sUA)
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.
Time frame: Baseline and Week 2, 6, 12, 16 (Follow-up)
Changes in Urinary Albumin-to-Creatinine Ratio (UACR)
Urinary Albumin-to-Creatinine Ratio from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Time frame: Baseline and Week 2, 6, 12, 16 (Follow-up)
Proportion of Subjects With a Greater Than 30% Reduction From Baseline to Week 12 in Urinary Albumin-to-Creatinine Ratio
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.
Time frame: 16 Weeks
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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
...and 45 more locations
Changes in Exploratory Blood Biomarkers (C Reactive Protein)
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.
Time frame: 16 Weeks
Changes in Exploratory Blood Biomarkers (Soluble TNF Receptor Type I)
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.
Time frame: 16 Weeks
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Fatty Acid Binding Protein 1)
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.
Time frame: 16 Weeks
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Hydroxy Deoxyguanosine)
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.
Time frame: 16 Weeks
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Kidney Injury Molecule-1)
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.
Time frame: 16 Weeks
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase)
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.
Time frame: 16 Weeks