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.

Study Overview

• Status: Withdrawn
• Conditions: Proteinuric Renal Disease
• Intervention / Treatment: Drug: paricalcitol (initial dose 1 mcg orally per day)

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop Univ. Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: Winthrop University Hospital

Publications and helpful links

General Publications

• Fishbane S, Chittineni H, Packman M, Dutka P, Ali N, Durie N. Oral paricalcitol in the treatment of patients with CKD and proteinuria: a randomized trial. Am J Kidney Dis. 2009 Oct;54(4):647-52. doi: 10.1053/j.ajkd.2009.04.036. Epub 2009 Jul 12.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: May 3, 2007
• First Submitted That Met QC Criteria: May 3, 2007
• First Posted (Estimate): May 4, 2007

Study Record Updates

• Last Update Posted (Estimate): December 28, 2015
• Last Update Submitted That Met QC Criteria: December 24, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: Z # 13178