NCT00469625

A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Winthrop University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Diabetic Nephropathy and other proteinuric renal diseases are the major cause of kidney disease in the United States. The degree of proteinuria is associated with risk for renal disease progression and cardiovascular outcomes. Deficiency of 1-25 Vitamin D develops early in CKD, and is undertreated. Vitamin D may have important effects on factors that drive proteinuria and renal disease progression in patients with proteinuric renal diseases. Therefore, Paricalcitol treatment may reduce proteinuria and slow renal deterioration.

Detailed description

Objectives: 1. To determine the effect of oral paricalcitol on protein excretion in patients with proteinuric renal diseases 2. To determine the effect of oral paricalcitol on renal disease progression in patients with proteinuric renal diseases Hypothesis: Oral paricalcitol will reduce protein excretion in proteinuric kidney disease Study Design: Prospective, randomized, placebo controlled, double blind, trial of paricalcitol compared to placebo. Sample Size: 60 patients, 30 in each group Summary of Patient Eligibility Criteria: Subjects with proteinuric renal disease (\>400 mg/24 hours) Randomization and Dosage: Patients will be randomized to treatment with oral paricalcitol (initial dose 1 mcg orally per day) compared to placebo Duration : 6 Months

Conditions

• Proteinuric Renal Disease

Interventions

Type	Name	Description
DRUG	paricalcitol (initial dose 1 mcg orally per day)

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2007-05-04
• Last updated: 2015-12-28

Locations

1 site across 1 country: United States