A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease

This study has been withdrawn prior to enrollment.
(Investigator left the Institution.)
Sponsor:
Information provided by:
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT00469625
First received: May 3, 2007
Last updated: December 24, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention
Proteinuric Renal Disease
Drug: paricalcitol (initial dose 1 mcg orally per day)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Enrollment: 0
Study Start Date: July 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00469625

Locations
United States, New York
Winthrop Univ. Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven Fishbane, MD, Winthrop-University Hospital
ClinicalTrials.gov Identifier: NCT00469625     History of Changes
Other Study ID Numbers: Z # 13178 
Study First Received: May 3, 2007
Last Updated: December 24, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 22, 2016