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Reducing Residual Albuminuria in Subjects With Diabetes & Nephropathy With Atrasentan - A Phase 2b, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Safety & Efficacy in Japanese Subjects
Prospective, randomized, double-blind, placebo controlled, 12-week, multicenter study. The objective of the study is to evaluate the efficacy and safety of once daily administration of atrasentan tablets compared to placebo in reducing residual albuminuria in Japanese Type 2 diabetic patients with nephropathy who are treated with the maximum tolerated labeled dose for hypertension of a RAS (renin angiotensin system) inhibitor.
Details
| Lead sponsor | AbbVie (prior sponsor, Abbott) |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 58 |
| Start date | 2011-08 |
| Completion | 2012-07 |
Conditions
- Chronic Kidney Disease
- Diabetic Nephropathy
Interventions
- Atrasentan low dose group
- Atrasentan high dose group
- Atrasentan placebo group
Primary outcomes
- The change from baseline to each post-baseline visit in log-transformed UACR (urinary albumin to creatinine ratio) — Up to Week 12
Countries
Japan