Pharmacokinetics of Immunosuppressive Drugs in Heart Transplant Patients
PIGREC
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.
1 other identifier
interventional
42
1 country
12
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2007
Longer than P75 for phase_4
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 19, 2008
CompletedFirst Posted
Study publicly available on registry
December 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJuly 30, 2025
December 1, 2008
3.8 years
December 19, 2008
July 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Estimation of the pharmacokinetic properties and parameters of the immunosuppressive drugs.
Secondary Outcomes (2)
Investigation of relationships between physiological and pathological characteristics and individual pharmacokinetic parameters.
Characterisation of the exposure-clinical effects relationships for the difference immunosuppressive drugs.
Interventions
Eligibility Criteria
You may qualify if:
- Patient at least 18 years old, male or female.
- Patient treated with one of the following combination : cyclosporine-mycophenolate, tacrolimus-mycophenolate or everolimus- "low-dose" cyclosporine for at least 3 days, and at least 24 hours by the oral route at the time of the first sampling day (between 7 and 15 days post-transplant).
- Patient included or not in another study, in particular in a therapeutic trial (e.g. comparison between drug combinations).
- Patient having given written informed consent for his/her participation to the trial.
You may not qualify if:
- Patients in disagreement with the present trial.
- Patients suffering from neuro-psychic problems, making them unable to well-understand the protocol or to give a reliable consent.
- Patients with previous heart or any other solid organ transplantation.
- Patients with double transplantation (heart-lung, heart-kidney or heart-liver)
- Patients still intubated and ventilated 15 days post-transplant.
- Patients with anaemia between Day 7 and 15, as characterized by hematocrit \< 30% or haemoglobin \< 9 g/dl.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
CHU de Bordeaux
Bordeaux, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
CHU de Lille
Lille, France
CHU de Limoges
Limoges, France
Hôpital Louis Pradel - CHU de Lyon
Lyon, France
CHU de Nantes
Nantes, France
Hôpital Européen Georges Pompidou
Paris, France
Hôpital Pitié-Salpêtrière
Paris, France
CHU de Rennes
Rennes, France
CHU de Rouen
Rouen, France
CHU de Strasbourg
Strasbourg, France
CHU de NANCY
Vandœuvre-lès-Nancy, France
Related Publications (1)
Woillard JB, Saint-Marcoux F, Monchaud C, Youdarene R, Pouche L, Marquet P. Mycophenolic mofetil optimized pharmacokinetic modelling, and exposure-effect associations in adult heart transplant recipients. Pharmacol Res. 2015 Sep;99:308-15. doi: 10.1016/j.phrs.2015.07.012. Epub 2015 Jul 17.
PMID: 26192348RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre MARQUET, MD
University Hospital, Limoges
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2008
First Posted
December 22, 2008
Study Start
July 1, 2007
Primary Completion
May 1, 2011
Study Completion
May 1, 2012
Last Updated
July 30, 2025
Record last verified: 2008-12