Pharmacokinetics of Immunosuppressive Drugs in Heart Transplant Patients (PIGREC)
|ClinicalTrials.gov Identifier: NCT00812786|
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : August 26, 2013
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).
|Condition or disease||Intervention/treatment||Phase|
|Heart Transplant||Drug: cyclosporine, tacrolimus, mycophenolate mofetil and everolimus (immunosuppressive drugs)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicentre, Open Study for the Setting up of Population Pharmacokinetic Models and Bayesian Estimators for Individual Dose Adjustment of Immunosuppressive Drugs (Cyclosporine, Tacrolimus, Mycophenolate Mofetil, Everolimus) During the First Year Post-grafting in Adult Heart Transplant Recipients.|
|Study Start Date :||July 2007|
|Primary Completion Date :||May 2011|
|Study Completion Date :||May 2012|
- Estimation of the pharmacokinetic properties and parameters of the immunosuppressive drugs.
- Investigation of relationships between physiological and pathological characteristics and individual pharmacokinetic parameters.
- Characterisation of the exposure-clinical effects relationships for the difference immunosuppressive drugs.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812786
|CHU de Bordeaux|
|CHU de Clermont-Ferrand|
|CHU de Lille|
|CHU de Limoges|
|Hôpital Louis Pradel - CHU de Lyon|
|CHU de Nantes|
|Hôpital Européen Georges Pompidou|
|CHU de Rennes|
|CHU de Rouen|
|CHU de Strasbourg|
|CHU de NANCY|
|Vandoeuvre Les Nancy, France|
|Principal Investigator:||Pierre MARQUET, MD||University Hospital, Limoges|