| Outcome Measures: |
Primary: 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., Baseline and Week 12 | Secondary: 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., 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., 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., 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., 16 Weeks|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., 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., 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., 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., 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., 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., 16 Weeks
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| Locations: |
AKDHC Medical Research Services, LLC, Flagstaff, Arizona, 86001, United States|Aventiv Research Inc., Mesa, Arizona, 85210, United States|Comprehensive Research Institute, Alhambra, California, 91801, United States|California Kidney Specialists, Covina, California, 91723, United States|Torrance Clinical Research Institute, Inc., Lomita, California, 90717, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|Diabetes Associates Medical Group, Orange, California, 92868, United States|Desert Oasis Healthcare Medical Group, Palm Springs, California, 92262, United States|California Kidney Specialists, San Dimas, California, 91773, United States|North America Research Institute, San Dimas, California, 91773, United States|San Marcus Research Clinic, Inc., Miami Lakes, Florida, 33014, United States|Leon Medical Research, Miami, Florida, 33015, United States|Endocrine Associates of Florida, P.A., Ocoee, Florida, 34761, United States|Pines Care Research Center, Pembroke Pines, Florida, 33026, United States|Hanson Clinical Research Center, Port Charlotte, Florida, 33952, United States|Nephrology Associates, PC, Augusta, Georgia, 30901, United States|Southeastern Clinical Research Institute, Augusta, Georgia, 30909, United States|East-West Medical Research Institute, Honolulu, Hawaii, 96814, United States|Solaris Clinical Research, Llc, Meridian, Idaho, 83646, United States|Associate in Endocrinology, Elgin, Illinois, 60124, United States|Community Clinical Research Center, Anderson, Indiana, 46011, United States|Community Hospital of Anderson and Madison County, Inc., Anderson, Indiana, 46011, United States|Iowa Kidney Physicians, Des Moines, Iowa, 50265, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States|My Kidney Center, LLC., Manhattan, Kansas, 66502, United States|Cotton O'Neil Clinical Research Center, Topeka, Kansas, 66606, United States|Four Rivers Clincial Research, Paducah, Kentucky, 42003, United States|Ochsner Clinic Foundation, Baton Rouge, Baton Rouge, Louisiana, 70809, United States|Biolab Research LLC, Rockville, Maryland, 20852, United States|Aa Mrc Llc, Flint, Michigan, 48504, United States|Elite Research Center LLC, Flint, Michigan, 48532, United States|Endocrine Consultants of Mid Michigan, Flint, Michigan, 48532, United States|Seacost Kidney & Hypertension Specialists, Portsmouth, New Hampshire, 03801, United States|Albany Medical College, Division of Community Endocinology, Albany, New York, 12206, United States|Randolph Health Internal Medicine, Asheboro, North Carolina, 27203, United States|Carteret Medical Group, Morehead City, North Carolina, 28557, United States|PMG Research of Wilmington, LLC, Wilmington, North Carolina, 28401, United States|Brookview Hills Research Associates, LLC, Winston-Salem, North Carolina, 27103, United States|Synexus Clinical Research US, Inc. Centennial Health, PC, Oklahoma City, Oklahoma, 73111, United States|Detweiler Family Medicine & Associates, PC, Lansdale, Pennsylvania, 19446, United States|University Diabetes & Endocrine Consultants, Chattanooga, Tennessee, 37411, United States|Knoxville Kidney Center, PLLC, Knoxville, Tennessee, 37923, United States|Texas Health Physicians Group, Dallas, Texas, 75243, United States|The Medical Group of Texas, Fort Worth, Texas, 76116, United States|Rockwood Medical Clinic, Fort Worth, Texas, 76164, United States|Endocrine Associates, Houston, Texas, 77004, United States|Juno Research, LLC, Houston, Texas, 77040, United States|The Endocrine Center, Houston, Texas, 77079, United States|Pioneer Research Solutions INC, Houston, Texas, 77099, United States|Houston Nephrology Research, Houston, Texas, 77429, United States|Clinical Advancement Center, PLLC, San Antonio, Texas, 78212, United States|BFHC Research, San Antonio, Texas, 78249, United States|Carl R. Meisner Medical Clinic, PLLC, Sugar Land, Texas, 77478, United States|University of Utah School of Medicine, Salt Lake City, Utah, 84108, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States
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