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

This study has been completed.
Information provided by:
Abbott Identifier:
First received: January 30, 2003
Last updated: July 31, 2006
Last verified: July 2006
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 Intervention Phase
Secondary Hyperparathyroidism
End Stage Renal Disease
Drug: paricalcitol injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis

Resource links provided by NLM:

Further study details as provided by Abbott:

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.

Estimated Enrollment: 28
Study Start Date: January 2002

Ages Eligible for Study:   2 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Subjects ages 2-20 with ESRD on hemodialysis with Secondary hyperparathyroidism
  Contacts and Locations
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Please refer to this study by its identifier: NCT00053547

United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Florida
Miami Children's Hospital
Miami, Florida, United States
United States, New York
The Children's Hospital of Buffalo
Buffalo, New York, United States
United States, Texas
Texas Children's Hospital
Houston, Texas, United States
University of Texas at Houston
Houston, Texas, United States
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Study Director: Laura Williams, M.D. Abbott
  More Information Identifier: NCT00053547     History of Changes
Other Study ID Numbers: 2001-022 
Study First Received: January 30, 2003
Last Updated: July 31, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperparathyroidism, Secondary
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Endocrine System Diseases
Kidney Diseases
Parathyroid Diseases
Renal Insufficiency
Urologic Diseases processed this record on May 26, 2016