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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:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00053547
First received: January 30, 2003
Last updated: July 31, 2006
Last verified: July 2006

January 30, 2003
July 31, 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Secondary Hyperparathyroidism
  • End Stage Renal Disease
Drug: paricalcitol injection
Not Provided
Not Provided

*   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

Both
2 Years to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00053547
2001-022
Not Provided
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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