Pilot Trial for Implementation of a MPA PK Monitoring Strategy

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.

Inclusion criteria

• primary or secondary cadaveric or living donor kidney recipients
• On Cellcept

Exclusion criteria

• Multi organ recipients
• Documented non-compliance
• Not on a calcineurin inhibitor
• GFR <25 ml/min by Cockcroft Gault equation
• Serum albumin <2.5 mg/dl
• Pregnant
• Active serious digestive disorder