Status:
COMPLETED
PK-PD Study of Mycophenolic Acid (CellCept) in Pediatric Kidney Transplant Patients
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Kidney Transplant
Eligibility:
All Genders
2-17 years
Brief Summary
The purpose of this study is to determine how fast children, who have had a recent kidney transplant, absorb, breakdown and eliminate mycophenolic acid (CellCept) following their prescribed dose. The ...
Detailed Description
This is an open-label, inpatient-outpatient population pharmacokinetic-pharmacodynamic (PK-PD) study of mycophenolic acid (MPA) in pediatric subjects (age 2-17 years) who have had a recent kidney tran...
Eligibility Criteria
Inclusion
- Male subjects and non-pregnant female subjects aged 2 to 17 years who are about to receive a kidney transplant and will be on post transplant MMF containing immunosuppressive therapy. Subjects may be enrolled up to their 18th year.
- Minimum weight of 11 kg.
- A signed and dated IRB approved parental / guardian informed consent form and an IRB-approved child assent form if applicable.
- A high probability for compliance with and completion of the study.
- For post-transplant study period: Subjects with stable kidney allografts who are at least 3 months post-transplant and who have received the same regimen of MMF (with cyclosporine or tacrolimus) for at least 30 days before the study visit (3-6 months post-transplant).
- 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.
- Other variations from established normal ranges may be acceptable if they are not clinically significant in the opinion of the investigators.
Exclusion
- Any medical condition (active or chronic) or prior surgery that may interfere with the pharmacokinetic behavior of MMF (absorption, distribution and elimination) as determined by the PI.
- Active systemic infection.
- History of substance abuse.
- Signs or symptoms of active hepatitis (a history of hepatitis B or C virus infection is permitted).
- Known history of or suspected infection with human immunodeficiency virus (HIV).
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00281619
Start Date
January 1 2006
End Date
February 1 2010
Last Update
December 19 2013
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229