PK-PD Study of Mycophenolic Acid (CellCept) in Pediatric Kidney Transplant Patients

Completed

Conditions studied: Kidney Transplant

In brief

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 results may lead to better dosing based on individual needs.

Key facts

Study ID

NCT00281619

Run by

Children's Hospital Medical Center, Cincinnati

People needed

29

Starts

2006-01-01

Expected to finish

2010-02-01

Last updated by the study team

2013-12-19

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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