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NCT00053547 Clinical Trial

Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis

End Stage Renal Disease Clinical Trial

Official title:
Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00053547
Other study ID # 2001-022
Secondary ID
Status Completed
Phase Phase 4
First received January 30, 2003
Last updated July 31, 2006
Start date January 2002

Study information
Verified date July 2006
Source Abbott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 20 Years
Eligibility Subjects ages 2-20 with ESRD on hemodialysis with Secondary hyperparathyroidism

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• paricalcitol injection

Locations
Country Name City State
United States The Children's Hospital of Buffalo Buffalo New York
United States Texas Children's Hospital Houston Texas
United States University of Texas at Houston Houston Texas
United States Miami Children's Hospital Miami Florida
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Stanford University Medical Center Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of subjects achieving at least a 30% decrease from baseline iPTH sustained for at least two consecutive iPTH measurements.
Secondary Proportion of subjects in each group who achieve two consecutive iPTH values below 300 pg/mL.
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