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Safety and Effectiveness of Zemplar Injection in decreasing iPTH levels in pediatric ESRD subjects on hemodialysis - Article


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Paricalcitol Injection

paricalcitol; Zemplar


Clinical Trial: Safety and Effectiveness of Zemplar Injection in decreasing iPTH levels in pediatric ESRD subjects on hemodialysis

This study has been completed.

Sponsored by: Abbott Laboratories
Information provided by: Abbott Laboratories

Purpose

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.

Condition Treatment or Intervention Phase
Secondary Hyperparathyroidism
End Stage Renal Disease
 Drug: paricalcitol injection
Phase IV

MedlinePlus related topics:  Kidney Failure;   Parathyroid Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Further Study Details: 

Expected Total Enrollment:  28

Study start: January 2002;  Study completion: January 2003

Eligibility

Ages Eligible for Study:  2 Years   -   20 Years,  Genders Eligible for Study:  Both

Criteria

Subjects ages 2-20 with ESRD on hemodialysis with Secondary hyperparathyroidism

Location Information


California
      Stanford University Medical Center, Stanford,  California,  94305,  United States

Florida
      Miami Children's Hospital, Miami,  Florida,  United States

New York
      The Children's Hospital of Buffalo, Buffalo,  New York,  United States

Texas
      Texas Children's Hospital, Houston,  Texas,  United States

      University of Texas at Houston, Houston,  Texas,  United States

Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  United States

Study chairs or principal investigators

Dheerendra Kommala, M.D.,  Abbott Laboratories   

More Information

Study ID Numbers:  2001-022
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  January 30, 2003
ClinicalTrials.gov Identifier:  NCT00053547
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 7, 2008



Page Updated: September 6, 2005
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