- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00812786
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.
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Bordeaux, France
- CHU de Bordeaux
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Clermont-ferrand, France
- CHU de Clermont-Ferrand
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Lille, France
- CHU de Lille
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Limoges, France
- CHU de Limoges
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Lyon, France
- Hôpital Louis Pradel - CHU de Lyon
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Nantes, France
- CHU de Nantes
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Paris, France
- Hôpital Pitié-Salpétrière
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Paris, France
- Hopital Europeen Georges Pompidou
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Rennes, France
- CHU de Rennes
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Rouen, France
- CHU de Rouen
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Strasbourg, France
- CHU de Strasbourg
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Vandoeuvre Les Nancy, France
- Chu de Nancy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient having received of a heart transplant (exclusively) less than 2 weeks before the inclusion date or planned to receive it within days following inclusion.
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Estimation of the pharmacokinetic properties and parameters of the immunosuppressive drugs.
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Secondary Outcome Measures
Outcome Measure |
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Investigation of relationships between physiological and pathological characteristics and individual pharmacokinetic parameters.
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Characterisation of the exposure-clinical effects relationships for the difference immunosuppressive drugs.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre MARQUET, MD, University Hospital, Limoges
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Dermatologic Agents
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Antitubercular Agents
- Antibiotics, Antitubercular
- Calcineurin Inhibitors
- Tacrolimus
- Mycophenolic Acid
- Everolimus
- Cyclosporine
- Cyclosporins
- Immunosuppressive Agents
Other Study ID Numbers
- 2006-006832-23
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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