NCT00920764

A Study of Atrasentan on Reducing Albuminuria in Type 2 Diabetic Nephropathy Treated With Renin-Angiotensin System Inhibitors

A Phase 2a, Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Safety and Efficacy of Atrasentan on Reducing Albuminuria in Type 2 Diabetic Nephropathy Subjects Who Are Currently Being Treated With an Renin-Angiotensin System Inhibitor

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Kidney Disease
• Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	Placebo for Atrasentan 0.2 mg/mL solution	10 mL oral solution, daily, 8 weeks
DRUG	0.25 mg Atrasentan QD	10 mL oral solution, daily, 8 weeks
DRUG	0.75 mg Atrasentan QD	10 mL oral solution, daily, 8 weeks
DRUG	1.75 mg Atrasentan QD	10 mL oral solution, daily, 8 weeks

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2009-06-15
• Last updated: 2018-06-06

Locations

28 sites across 2 countries: United States, Puerto Rico