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Genetic Drug Study of Mycophenolic Acid (CellCept) in Pediatric Kidney Transplant Patients

NCT00433953 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2013-02-20

No results posted yet for this study

Summary

The purpose of this study is to determine how genes influence the response to mycophenolate mofetil (CellCept) in children who have had a kidney transplant. The study will look at how differences in some genes effect blood levels of mycophenolate mofetil over time in children, how often side effects occur and the way that children respond to mycophenolate mofetil.

The results may lead to better dosing based on individual needs.

Conditions

  • Kidney Transplant

Interventions

DRUG

Mycophenolate Mofetil (CellCept)

BEHAVIORAL

Dietary Monitoring

BEHAVIORAL

Drug Diary

PROCEDURE

Blood Sampling

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Alexander A. Vinks, Pharm.D., Ph.D. · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00433953 on ClinicalTrials.gov