NCT00421733

The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors

VITAL Study - Selective VITamin D Receptor Activator (Paricalcitol) for Albuminuria Lowering Study: A Phase 2, Prospective, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules on Reducing Albuminuria in Type 2 Diabetic Nephropathy Subjects Who Are Currently Being Treated With Renin-angiotensin System Inhibitors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The study objective was to evaluate the safety of paricalcitol capsules and the efficacy of paricalcitol capsules for albuminuria reduction in patients with Chronic Kidney Disease (CKD) who have Type 2 diabetic nephropathy and are receiving optimal angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blocker (ARB) therapy.

Conditions

• Diabetic Nephropathy
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Zemplar (paricalcitol ) capsules	Group 2 - paricalcitol 1 mcg capsules once daily (one paricalcitol 1 mcg capsule once daily and one matching placebo capsule once daily)
DRUG	Zemplar (paricalcitol) capsules	Group 3 - paricalcitol 2 mcg capsules once daily (two paricalcitol 1 mcg capsules once daily)
DRUG	Placebo	Group 1 - Placebo once daily (two placebo capsules once daily)

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-01-12
• Last updated: 2012-01-20
• Results posted: 2010-09-14

Locations

72 sites across 10 countries: United States, Germany, Greece, Italy, Netherlands, Poland, Portugal, Puerto Rico, Spain, Taiwan