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

This study has been completed.

First Received: January 30, 2003 Last Updated: July 31, 2006 History of Changes

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00053547

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: 19-Nor-1alpha,25-dihydroxyvitamin D2

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

Study ID Numbers:	2001-022
Study First Received:	January 30, 2003
Last Updated:	July 31, 2006
ClinicalTrials.gov Identifier:	NCT00053547 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Parathyroid Diseases
Renal Insufficiency
Hyperparathyroidism, Secondary
Urologic Diseases
Hyperparathyroidism
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Neoplasm Metastasis
Endocrine System Diseases
Endocrinopathy
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Parathyroid Diseases
Renal Insufficiency
Hyperparathyroidism, Secondary
Urologic Diseases
Hyperparathyroidism

Renal Insufficiency, Chronic
Kidney Failure, Chronic
Endocrine System Diseases
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on September 11, 2009