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Clinical Trial Details

Trial ID: L2152
Source ID: NCT03217591
Associated Drug: Iw-1973
Title: A Study to Evaluate the Soluble Guanylate Cyclase (sGC) Stimulator IW-1973 in Diabetic Nephropathy / Diabetic Kidney Disease as Measured by Albuminuria
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03217591/results
Conditions: Type 2 Diabetes Mellitus With Diabetic Nephropathy
Interventions: DRUG: IW-1973|DRUG: IW-1973|DRUG: Placebo
Outcome Measures: Primary: Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs, An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those AEs that started or worsened in severity after the initiation of study drug administration. Causality relationship to study drug was per Investigator assessment., Day 1 up to Day 115|Percent Change From Baseline in Urine Albumin Creatinine Ratio (UACR) Over Weeks 8 and 12, Urine samples were collected for the analysis of UACR. UACR (milligrams per gram \[mg/g\]) was calculated as urine albumin (mg per deciliter \[mg/dL\]) / urine creatinine (g/dL). Change from Baseline was calculated as the average of the UCAR values at Weeks 8 and 12 minus the Baseline value. Data were analyzed using a mixed-effects model repeated measures (MMRM) analysis with change from Baseline in log-transformed UACR as the response variable, treatment, visit, treatment-by visit interaction, and Baseline estimated glomerular filtration rate stratum as fixed effects, Baseline log-transformed UACR and Baseline mean arterial pressure as covariates, and unstructured as the variance-covariance structure., Baseline; Week 8 to Week 12 |
Sponsor/Collaborators: Sponsor: Akebia Therapeutics | Collaborators: Cyclerion Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 156
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-08-01
Completion Date: 2019-08-20
Results First Posted: 2022-09-15
Last Update Posted: 2022-09-15
Locations: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States|California Institute of Renal Research, Chula Vista, California, 91910, United States|St. Joseph Heritage Healthcare (St. Jude Hospital DBA), Fullerton, California, 92835, United States|California Institute of Renal Research, La Mesa, California, 91942, United States|Torrance Clinical Research Institute, Inc., Lomita, California, 90717, United States|American Institute of Research, Los Angeles, California, 90017, United States|Academic Medical Research Institute, Los Angeles, California, 90022, United States|California Medical Research Associates, Inc. (CMRA), Northridge, California, 91324, United States|Riverside Nephrology Physicians, Inc., Riverside, California, 92503, United States|California Kidney Specialists, San Dimas, California, 91773, United States|North American Research Institute, San Dimas, California, 91773, United States|UCLA, Santa Monica, California, 90025, United States|Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California, 90502, United States|Creekside Endocrine Associates, Denver, Colorado, 80209, United States|Christiana Care Health Services, Newark, Delaware, 19713, United States|The George Washington University Medical Faculty Associates, Washington, District of Columbia, 20037, United States|AGA Clinical Trials, Hialeah, Florida, 33012, United States|Sweet Hope Research Speciality, Inc., Miami Lakes, Florida, 33016, United States|Leon Medical Research Corp., Miami, Florida, 33015, United States|Elite Clinical Research, Miami, Florida, 33144, United States|DL Research Solutions, Miami, Florida, 33155, United States|Premier Research Associates, Inc., Miami, Florida, 33165, United States|IMIC, Inc., Palmetto Bay, Florida, 33157, United States|Atlanta Center for Clinical Research Nephrology, Atlanta, Georgia, 30342, United States|Columbus Regional Research Institute, Columbus, Georgia, 31904, United States|Gwinnett Biomedical Research, Lawrenceville, Georgia, 30046, United States|East Coast Institute for Clinical Research, Macon, Georgia, 31210, United States|East Coast Institute for Research, Macon, Georgia, 31210, United States|Saltzer Medical Group, Nampa, Idaho, 83686, United States|Research by Design, LLC, Chicago, Illinois, 60643, United States|American Health Network of Indiana, Franklin, Indiana, 46131, United States|My Kidney Center, Manhattan, Kansas, 66502, United States|Kentucky Diabetes Endocrinology Center, Lexington, Kentucky, 40503, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|Aa Mrc, Llc, Flint, Michigan, 48504, United States|St. Louis Heart & Vascular, P.C., Saint Louis, Missouri, 63136, United States|NJ Heart, P.A., Linden, New Jersey, 07036, United States|Albany Medical College, Division of Community Endocrinology, Albany, New York, 12206, United States|Physicians East Endocrinology, Greenville, North Carolina, 27834, United States|Mountain View Clinical Research, Greer, South Carolina, 29651, United States|South Carolina Nephrology & Hypertension Center, Orangeburg, South Carolina, 29118, United States|University of Tennessee Health Science Center at Memphis University Hospital, Memphis, Tennessee, 38104, United States|Pioneer Research Solutions, Beaumont, Texas, 77702, United States|Academy of Diabetes, Thyroid and Endocrine, P.A., El Paso, Texas, 79935, United States|The Medical Group of Texas, Fort Worth, Texas, 76116, United States|Rockwood Medical Center, Fort Worth, Texas, 76164, United States|Endocrine IPS, PLLC, Houston, Texas, 77079, United States|Pioneer Research Solutions, Inc., Houston, Texas, 77099, United States|FMC Science, LLC, Lampasas, Texas, 76550, United States|Clinical Advancement Center PLLC, San Antonio, Texas, 78215, United States|Briggs Clinical Research, San Antonio, Texas, 78224, United States|Burke Internal Medicine and Research, Burke, Virginia, 22015, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States|Northside Endocrinology, Spokane, Washington, 99208, United States
URL: https://clinicaltrials.gov/show/NCT03217591

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress