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Withdrawn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
About this trial
This is an interventional treatment trial for Proteinuric Renal Disease
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
Sites / Locations
- Winthrop Univ. Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00469625
First Posted
May 3, 2007
Last Updated
December 24, 2015
Sponsor
Winthrop University Hospital
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Withdrawn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
derived
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A Study Of Oral Paricalcitol To Treat Proteinuric Renal Disease
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