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This study has been withdrawn prior to enrollment.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

May 3, 2007
December 24, 2015
July 2006
January 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00469625 on ClinicalTrials.gov Archive Site
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A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease
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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Proteinuric Renal Disease
Drug: paricalcitol (initial dose 1 mcg orally per day)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00469625
Z # 13178
No
Not Provided
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Steven Fishbane, MD, Winthrop-University Hospital
Winthrop University Hospital
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Not Provided
Winthrop University Hospital
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP