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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00053547
First Posted: February 3, 2003
Last Update Posted: August 2, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
January 30, 2003
February 3, 2003
August 2, 2006
January 2002
Not Provided
Proportion of subjects achieving at least a 30% decrease from baseline iPTH sustained for at least two consecutive iPTH measurements.
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Complete list of historical versions of study NCT00053547 on ClinicalTrials.gov Archive Site
Proportion of subjects in each group who achieve two consecutive iPTH values below 300 pg/mL.
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Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis
Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
  • Secondary Hyperparathyroidism
  • End Stage Renal Disease
Drug: paricalcitol injection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
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Subjects ages 2-20 with ESRD on hemodialysis with Secondary hyperparathyroidism
Sexes Eligible for Study: All
2 Years to 20 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00053547
2001-022
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Abbott
Not Provided
Study Director: Laura Williams, M.D. Abbott
Abbott
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP