A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease

Winthrop University Hospital1 site in 1 countryJuly 2006

ConditionsProteinuric Renal Disease

Drugsparicalcitol (initial dose 1 mcg orally per day)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Proteinuric Renal Disease
Sponsor: Winthrop University Hospital
Locations: 1
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

July 2006

End Date

January 2008

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group