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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
  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
Intervention Model: Single Group Assignment
Masking: Double
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Subjects ages 2-20 with ESRD on hemodialysis with Secondary hyperparathyroidism
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00053547     History of Changes
Other Study ID Numbers: 2001-022
First Submitted: January 30, 2003
First Posted: February 3, 2003
Last Update Posted: August 2, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
Kidney Failure, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Parathyroid Diseases
Endocrine System Diseases