NCT00053547

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2003

Completed
Last Updated

August 2, 2006

Status Verified

July 1, 2006

First QC Date

January 30, 2003

Last Update Submit

July 31, 2006

Conditions

Secondary HyperparathyroidismEnd Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

paricalcitol injectionDRUG

Eligibility Criteria

Age2 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Subjects ages 2-20 with ESRD on hemodialysis with Secondary hyperparathyroidism

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Miami Children's Hospital

Miami, Florida, United States

Location

The Children's Hospital of Buffalo

Buffalo, New York, United States

Location

Texas Children's Hospital

Houston, Texas, United States

Location

University of Texas at Houston

Houston, Texas, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Location

MeSH Terms

Conditions

Hyperparathyroidism, SecondaryKidney Failure, Chronic

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Laura Williams, M.D.

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 30, 2003

First Posted

February 3, 2003

Study Start

January 1, 2002

Last Updated

August 2, 2006

Record last verified: 2006-07

Locations

US(6)