The study objective is to investigate the effects of three low doses of atrasentan on urinary albumin/creatinine ratio (UACR) levels in subjects with Type 2 diabetic nephropathy. Patients with Type 2 diabetes with nephropathy must be receiving a renin-angiotensin system inhibitor, such as an Angiotensin converting enzyme inhibitor (ACEi) or an Angiotensin II Receptor Blocker (ARB) for participation in this study. ACEi and ARB treatment are the standard of care for the management of proteinuria in Chronic Kidney Disease (CKD) patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
10 mL oral solution, daily, 8 weeks
10 mL oral solution, daily, 8 weeks
10 mL oral solution, daily, 8 weeks
10 mL oral solution, daily, 8 weeks
Site Reference ID/Investigator# 19386
Tempe, Arizona, United States
Site Reference ID/Investigator# 25043
Azusa, California, United States
Site Reference ID/Investigator# 23308
Los Angeles, California, United States
Site Reference ID/Investigator# 25430
Los Angeles, California, United States
Site Reference ID/Investigator# 20421
San Diego, California, United States
Mean change from baseline to each post-baseline observation on UACR over the course of treatment period versus standard of care
Time frame: Week 8 visit or final assessment
Proportion of subjects achieving at least a 25% reduction in final UACR levels from baseline
Time frame: Week 8 visit or final assessment
Proportion of subjects achieving at least a 40% reduction in final UACR levels from baseline
Time frame: Week 8 visit or final assessment
Change from baseline to the final value in UACR, estimated glomerular filtration rate (eGFR), Neutrophil Gelatinase-Associated Lipocalin (NGAL)
Time frame: Week 8 visit or final assessment
Change from baseline to each weekly measurement in NGAL
Time frame: Week 8 visit or final assessment
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Site Reference ID/Investigator# 22442
San Diego, California, United States
Site Reference ID/Investigator# 21061
Whittier, California, United States
Site Reference ID/Investigator# 16572
Yuba City, California, United States
Site Reference ID/Investigator# 26142
Coral Gables, Florida, United States
Site Reference ID/Investigator# 16567
Hudson, Florida, United States
...and 18 more locations