Pharmacokinetics of Immunosuppressive Drugs in Heart Transplant Patients
Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
The main objective is to develop pharmacokinetic methods for individual dose adjustment of
the global immunosuppressive treatment (cyclosporine, tacrolimus, mycophenolate mofetil and
everolimus, taking into account the pharmacokinetic interactions), in order to optimise the
efficiency and reduce the potentially severe sides effects of these drugs.
Forty five heart-transplant patients are to be included in this phase IV study to obtain a
minimum of 10 patients treated with tacrolimus-mycophenolate, 10 with
cyclosporine-mycophenolate and 20 with everolimus-cyclosporine.
Ten to 11 blood samples will be collected within the 8 to 12 hours post-dose in each patient
and the immunosuppressive drug concentrations will be measured by LC-MS/MS.
The pharmacokinetic models and Bayesian estimators thus developed will provide tools for
individual dose adjustment of immunosuppressive drugs simultaneously, at different
post-transplant periods, using the area under the concentration-time curve (AUC) estimated
using a limited number of time-points (2 or 3).