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A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease

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ClinicalTrials.gov Identifier: NCT00469625
Recruitment Status : Withdrawn (Investigator left the Institution.)
First Posted : May 4, 2007
Last Update Posted : December 28, 2015
Sponsor:
Information provided by:
Winthrop University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Proteinuric Renal Disease Drug: paricalcitol (initial dose 1 mcg orally per day) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease
Study Start Date : July 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469625


Locations
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United States, New York
Winthrop Univ. Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Steven Fishbane, MD, Winthrop-University Hospital
ClinicalTrials.gov Identifier: NCT00469625    
Other Study ID Numbers: Z # 13178
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: December 28, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases