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

NCT00433953 | Terminated Phase 1

• 1 other identifier: 06-06-44
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pediatric Kidney Transplant; Kidney Transplant; CellCept; Mycophenolate Mofetil; Mycophenolic Acid

Outcome Measures

Primary Outcomes (3)

• The following outcome measures will be performed at the study visit after the patient is on a steady state dose of mycophenolate mofetil:

  Day 1

• Drug measurement of MPA, MPA-G and acyl-MPA-G

  Day 1

• Genomic DNA extraction using standard procedures. Patients will be genotyped for the UGT2B7, UGT1A8, UGT1A9 polymorphism.

  Day 1

Secondary Outcomes (5)

• Concomitant medications and mycophenolate mofetil drug diary

  Day 1

• Physical Exam

  Day 1

• Safety Laboratory tests

  Day 1

• Dietary Monitoring

  Day 1

• Adverse Event Reporting

  Day 1

Interventions

Mycophenolate Mofetil (CellCept) DRUG

Dietary Monitoring BEHAVIORAL

Drug Diary BEHAVIORAL

Blood Sampling PROCEDURE

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male subjects and non-pregnant female subjects aged 2 to 18 years who are about to receive a kidney transplant and will be on post transplant MMF containing immunosuppressive therapy.
• A signed and dated institutional review board (IRB) approved parental/guardian informed consent form and an IRB approved child assent form if applicable.
• Subjects with stable kidney allografts who are on a stable regimen of MMF (with tacrolimus and steroids)
• May have clinically important abnormalities on clinical and /or laboratory evaluations, only as these abnormalities relate to an underlying condition as determined by the principal investigator.

You may not qualify if:

• Children receiving cyclosporine therapy that may interact with MPA entero-hepatic recycling.
• Any medical condition(active or chronic) or prior surgery that may interfere with the pharmacokinetics of MMF as determined by the principal investigator.
• Concomitant medication that may interfere with the pharmacokinetics of MMF as determined by the principal investigator.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Interventions

Mycophenolic Acid; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Alexander A. Vinks, Pharm.D., Ph.D.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2007
• First Posted: February 12, 2007
• Study Start: February 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

US (1)