NCT01424319

Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With Atrasentan

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 20 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Kidney Disease
• Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	Atrasentan low dose group	Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period.
DRUG	Atrasentan high dose group	Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period.
DRUG	Atrasentan placebo group	Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-08-29
• Last updated: 2017-08-29

Locations

18 sites across 1 country: Japan