Gainesville, Florida 32610

  • Transplant, Kidney

Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00187915


Primary Contact:

Principal Investigator
Herwig-Ulf Meier-Kriesche, MD
University of Florida


Backup Contact:

N/A


Location Contact:

Gainesville, Florida 32610
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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