Pharmacokinetics of Immunosuppressive Drugs in Heart Transplant Patients (PIGREC)
Recruitment status was Recruiting
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).
Drug: cyclosporine, tacrolimus, mycophenolate mofetil and everolimus (immunosuppressive drugs)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|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.|
- 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.
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||May 2010|
|Estimated Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
For each heart transplant patient, 10 to 11 blood samples (5 mL each) will be collected following dosing of he immunosuppressive drugs (at T0, T20', T40', T60', T90', T2h, T3h, T4h, T6h, T8h and T10h + T12h for inpatients), at several post-transplant periods (7 to 15 days, 1 month, 3 month and 1 year after transplantation). One more blood sample will be taken at D7-14 for pharmacogenetic analyses.
|Contact: Pierre MARQUET, MDfirstname.lastname@example.org|
|CHU de Bordeaux||Recruiting|
|Sub-Investigator: Marc Alain BILLES, MD|
|CHU de Clermont-Ferrand||Not yet recruiting|
|Sub-Investigator: Etienne GEOFFROY, MD|
|CHU de Lille||Not yet recruiting|
|Sub-Investigator: Annie POL, MD|
|CHU de Limoges||Recruiting|
|Principal Investigator: Florence ROLLE, MD|
|Hôpital Louis Pradel - CHU de Lyon||Recruiting|
|Sub-Investigator: Laurent SEBBAG, MD|
|CHU de Nantes||Not yet recruiting|
|Sub-Investigator: T PETIT, MD|
|Hôpital Européen Georges Pompidou||Recruiting|
|Sub-Investigator: Romain GUILLEMAIN, MD|
|Hôpital Pitié-Salpêtrière||Not yet recruiting|
|Sub-Investigator: Shaida VARNOUS, MD|
|CHU de Rennes||Not yet recruiting|
|Sub-Investigator: Bernard LELONG, MD|
|CHU de Rouen||Recruiting|
|Sub-Investigator: Michel REDONNET, MD|
|CHU de Strasbourg||Not yet recruiting|
|Sub-Investigator: Eric EPAILLY, MD|
|CHU de NANCY||Not yet recruiting|
|Vandoeuvre Les Nancy, France|
|Sub-Investigator: Marie Françoise MATTEI, MD|
|Principal Investigator:||Pierre MARQUET, MD||University Hospital, Limoges|