A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease

Not Applicable

Withdrawn

• Conditions: Proteinuric Renal Disease

• Registration Number: NCT00469625
• Lead Sponsor: Winthrop University Hospital

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

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-04
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-24
• Last Update Posted: 2015-12-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Stable chronic kidney disease
2. Urine protein : Creatinine ratio > 0.4
3. Chronic kidney disease stage 2-4 with eGFR 15-90 ml/min
4. PTH (intact) >20 pg/ml and <250 pg/ml
5. Age 18-85
6. If on ACEI/ARB, then dose optimized (BP, K)

Exclusion Criteria

1. Failure to provide informed consent
2. Glomerunephritis requiring active treatment with immunosuppresive therapy
3. Serum phosphorus > 5.2
4. Serum calcium (adjusted for albumin)> 10.0
5. Active malignancy
6. Likelihood of requiring renal replacement therapy within 1 year
7. Uncontrolled hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Winthrop Univ. Hospital; 🇺🇸 Mineola, New York, United States