Proteinuric Renal Disease Clinical Trial
Official title:
A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment