Transplant, Kidney Clinical Trial
Official title:
Pilot Trial for Implementation of a MPA PK Monitoring Strategy
This study is a prospective interventional trial of de novo renal transplant recipients, aiming to validate a strategy which combines the use of early post transplant MPA AUC sampling, and subsequent MPA trough level monitoring to implement MPA PK monitoring in a clinically applicable fashion.
Mycophenolate mofetil or MMF (CellCept® by Roche) is the mofetil ester of mycophenolic acid
(MPA), the active immunosuppressant.
MMF significantly decreases the episodes of acute rejection in kidney transplant patients;
but as with any medication without adequate pharmacokinetic drug monitoring, the issue of
under or over immunosuppression arises. For this reason, the biggest challenge lies with
establishing a feasible mean of MPA pharmacokinetic monitoring. Thus far no study has shown
that measuring MPA trough levels alone correlates with rejection, unlike MPA Area Under the
concentration time Curve (AUC), due to the large incidence of inter- and intra-patient
variability.
This is the first prospective blinded trial set up to analyze the correlation between
individualized MPA AUC and trough levels of kidney transplant patients in hopes of
establishing a more efficacious way of monitoring MPA. MPA target trough levels that
correspond to AUC greater than 30 mg x h/L could then be utilized as maintenance
measurements.
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment