To evaluate the safety and efficacy of IW-1973 in patients with type 2 diabetes mellitus with albuminuria who are on a stable regimen of renin-angiotensin system inhibitors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
156
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.
Time frame: 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.
Time frame: Baseline; Week 8 to Week 12
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University of Alabama at Birmingham
Birmingham, Alabama, United States
California Institute of Renal Research
Chula Vista, California, United States
St. Joseph Heritage Healthcare (St. Jude Hospital DBA)
Fullerton, California, United States
California Institute of Renal Research
La Mesa, California, United States
Torrance Clinical Research Institute, Inc.
Lomita, California, United States
American Institute of Research
Los Angeles, California, United States
Academic Medical Research Institute
Los Angeles, California, United States
California Medical Research Associates, Inc. (CMRA)
Northridge, California, United States
Riverside Nephrology Physicians, Inc.
Riverside, California, United States
California Kidney Specialists
San Dimas, California, United States
...and 44 more locations