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

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ClinicalTrials.gov Identifier: NCT00433953
Recruitment Status : Terminated (No longer following patient and no plans to publish.)
First Posted : February 12, 2007
Last Update Posted : February 20, 2013
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.


Condition or disease Intervention/treatment Phase
Kidney Transplant Drug: Mycophenolate Mofetil (CellCept) Behavioral: Dietary Monitoring Behavioral: Drug Diary Procedure: Blood Sampling Phase 1

Detailed Description:
This is an open label, inpatient-outpatient prospective observational study to determine whether the inter-patient variability in mycophenolic acid (MPA) pharmacokinetics and exposure, adverse events and clinical response in pediatric transplant patients (ages 2-18 years) is associated with identifiable pharmacogenetic factors. Specific aims: 1.) To determine whether common polymorphic variations in the uridine diphosphate-glucuronosyltransferases (UGTs) are associated with inter-individual variability in MPA pharmacokinetics and exposure (by affecting MPA metabolism). 2.) To determine whether common polymorphic variations in the uridine diphosphate-glucuronosyltransferases (UGTs) are associated with inter-patient differences in the incidence of adverse events (by affecting the formation of the acyl-glucuronide metabolite). Enrolled subjects will have been receiving mycophenolate mofetil as part of their clinical standard of care. It is anticipated that the clinical portion of the study will last up to 4 hours at one study visit to include one pharmacogenetic blood sample and 4 pharmacokinetic blood samples collected out to 3 hours post-dose. Safety data to be collected will include standard of care physical exam and safety laboratory tests as well as data on adverse events and clinical outcomes.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacogenetics of Mycophenolic Acid in Kidney Transplant Patients
Study Start Date : February 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010





Primary Outcome Measures :
  1. The following outcome measures will be performed at the study visit after the patient is on a steady state dose of mycophenolate mofetil: [ Time Frame: Day 1 ]
  2. Drug measurement of MPA, MPA-G and acyl-MPA-G [ Time Frame: Day 1 ]
  3. Genomic DNA extraction using standard procedures. Patients will be genotyped for the UGT2B7, UGT1A8, UGT1A9 polymorphism. [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Concomitant medications and mycophenolate mofetil drug diary [ Time Frame: Day 1 ]
  2. Physical Exam [ Time Frame: Day 1 ]
  3. Safety Laboratory tests [ Time Frame: Day 1 ]
  4. Dietary Monitoring [ Time Frame: Day 1 ]
  5. Adverse Event Reporting [ Time Frame: Day 1 ]


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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433953


Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Alexander A. Vinks, Pharm.D., Ph.D. Children's Hospital Medical Center, Cincinnati

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00433953     History of Changes
Other Study ID Numbers: 06-06-44
First Posted: February 12, 2007    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Pediatric Kidney Transplant
Kidney Transplant
CellCept
Mycophenolate Mofetil
Mycophenolic Acid

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action