Pilot Trial for Implementation of a MPA PK Monitoring Strategy
- Conditions
- Transplant, Kidney
- Interventions
- Registration Number
- NCT00187915
- Lead Sponsor
- University of Florida
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- primary or secondary cadaveric or living donor kidney recipients
- On Cellcept
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CellCept + Neoral Mycophenolate mofetil + Cyclosporin Standard of Care Regime CellCept + Prograf Mycophenolate mofetil + Tacrolimus Standard of Care Regime
- Primary Outcome Measures
Name Time Method Number of subjects with an average AUC between 30-60 ng x hr/mL 7 months
- Secondary Outcome Measures
Name Time Method Rate of acute rejection of transplanted kidney 7 months Number of MPA related toxicities 7 months Number of dose changes required to obtain MPA AUC target in the first month 7 months
Trial Locations
- Locations (1)
University of Florida
🇺🇸Gainesville, Florida, United States