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

Phase 4

Completed

• Conditions: Secondary Hyperparathyroidism; End Stage Renal Disease

• Registration Number: NCT00053547
• Lead Sponsor: Abbott

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2003-01-30
• Study First Submitted QC: 2003-02-01
• Study First Posted: 2003-02-03
• Status Verified: 2006-07
• Last Update Submitted: 2006-07-31
• Last Update Posted: 2006-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving at least a 30% decrease from baseline iPTH sustained for at least two consecutive iPTH measurements.

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects in each group who achieve two consecutive iPTH values below 300 pg/mL.

Trial Locations

Locations (6)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Miami Children's Hospital; 🇺🇸 Miami, Florida, United States

The Children's Hospital of Buffalo; 🇺🇸 Buffalo, New York, United States

University of Texas at Houston; 🇺🇸 Houston, Texas, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States