NCT00187915

Pilot Trial for Implementation of a MPA PK Monitoring Strategy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Transplant, Kidney

Interventions

Type	Name	Description
DRUG	Mycophenolate mofetil + Tacrolimus	Target MPA exposure to 30-60 mg/L/h during first month post-transplant
DRUG	Mycophenolate mofetil + Cyclosporin	Target MPA exposure to 30-60 mg/L/h during first month post-transplant

Timeline

• Start date: 2003-07-01
• Primary completion: 2004-11-01
• Completion: 2004-12-01
• First posted: 2005-09-16
• Last updated: 2011-10-20

Locations

1 site across 1 country: United States