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A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease

Primary Purpose

Proteinuric Renal Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
paricalcitol (initial dose 1 mcg orally per day)
Sponsored by
Winthrop University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proteinuric Renal Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Winthrop Univ. Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 3, 2007
Last Updated
December 24, 2015
Sponsor
Winthrop University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00469625
Brief Title
A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease
Official Title
A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator left the Institution.
Study Start Date
July 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Winthrop University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: To determine the effect of oral paricalcitol on protein excretion in patients with proteinuric renal diseases 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proteinuric Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paricalcitol (initial dose 1 mcg orally per day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable chronic kidney disease Urine protein : Creatinine ratio > 0.4 Chronic kidney disease stage 2-4 with eGFR 15-90 ml/min PTH (intact) >20 pg/ml and <250 pg/ml Age 18-85 If on ACEI/ARB, then dose optimized (BP, K) Exclusion Criteria: Failure to provide informed consent Glomerunephritis requiring active treatment with immunosuppresive therapy Serum phosphorus > 5.2 Serum calcium (adjusted for albumin)> 10.0 Active malignancy Likelihood of requiring renal replacement therapy within 1 year Uncontrolled hypertension
Facility Information:
Facility Name
Winthrop Univ. Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19596163
Citation
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.
Results Reference
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A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease

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