Pharmacokinetics of Immunosuppressive Drugs in Heart Transplant Patients (PIGREC)
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. [ Designated as safety issue: No ]
- Investigation of relationships between physiological and pathological characteristics and individual pharmacokinetic parameters. [ Designated as safety issue: No ]
- Characterisation of the exposure-clinical effects relationships for the difference immunosuppressive drugs.
|Study Start Date:||July 2007|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2011 (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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|