Status:
TERMINATED
Genetic Drug Study of Mycophenolic Acid (CellCept) in Pediatric Kidney Transplant Patients
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Kidney Transplant
Eligibility:
All Genders
2-18 years
Phase:
PHASE1
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 s...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00433953
Start Date
February 1 2007
End Date
February 1 2010
Last Update
February 20 2013
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229