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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
History of Changes
  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 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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   2 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053547

Locations
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
Abbott
Investigators
Study Director: Laura Williams, M.D. Abbott
  More Information

No publications provided

ClinicalTrials.gov 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
Hyperparathyroidism, Secondary
Kidney Diseases
Kidney Failure, Chronic
Parathyroid Diseases
 Endocrine System Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 23, 2013