Back to resultsSafety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis
Primary Purpose
Secondary Hyperparathyroidism, End Stage Renal Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
paricalcitol injection
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism
Eligibility Criteria
Subjects ages 2-20 with ESRD on hemodialysis with Secondary hyperparathyroidism
Sites / Locations
- Stanford University Medical Center
- Miami Children's Hospital
- The Children's Hospital of Buffalo
- Texas Children's Hospital
- University of Texas at Houston
- Medical College of Wisconsin
Outcomes
Primary Outcome Measures
Proportion of subjects achieving at least a 30% decrease from baseline iPTH sustained for at least two consecutive iPTH measurements.
Secondary Outcome Measures
Proportion of subjects in each group who achieve two consecutive iPTH values below 300 pg/mL.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00053547
Brief Title
Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis
Official Title
Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to see if Zemplar, a vitamin D medication, safely and effectively decreases parathyroid hormone in children ages 2-20 with End Stage Renal Disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, End Stage Renal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
28 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
paricalcitol injection
Primary Outcome Measure Information:
Title
Proportion of subjects achieving at least a 30% decrease from baseline iPTH sustained for at least two consecutive iPTH measurements.
Secondary Outcome Measure Information:
Title
Proportion of subjects in each group who achieve two consecutive iPTH values below 300 pg/mL.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subjects ages 2-20 with ESRD on hemodialysis with Secondary hyperparathyroidism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Williams, M.D.
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
Country
United States
Facility Name
The Children's Hospital of Buffalo
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
Country
United States
Facility Name
University of Texas at Houston
City
Houston
State/Province
Texas
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis
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