Pharmacokinetics of Immunosuppressive Drugs in Heart Transplant Patients (PIGREC)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University Hospital, Limoges.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital, Limoges
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00812786
First received: December 19, 2008
Last updated: December 30, 2008
Last verified: December 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Heart Transplant |
Drug: cyclosporine, tacrolimus, mycophenolate mofetil and everolimus (immunosuppressive drugs) |
Phase 4 |
| Study Type: | Interventional |
| 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. |
Resource links provided by NLM:
MedlinePlus related topics:
Heart Transplantation
Drug Information available for:
Mycophenolic acid
Mycophenolate sodium
Sirolimus
Cyclosporine
Tacrolimus
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
Everolimus
Temsirolimus
U.S. FDA Resources
Further study details as provided by University Hospital, Limoges:
Primary Outcome Measures:
- Estimation of the pharmacokinetic properties and parameters of the immunosuppressive drugs.
Secondary Outcome Measures:
- Investigation of relationships between physiological and pathological characteristics and individual pharmacokinetic parameters.
- Characterisation of the exposure-clinical effects relationships for the difference immunosuppressive drugs.
| Estimated Enrollment: | 45 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812786
Contacts
| Contact: Pierre MARQUET, MD | pierre.marquet@unilim.fr |
Locations
| France | |
| CHU de Bordeaux | Recruiting |
| Bordeaux, France | |
| Sub-Investigator: Marc Alain BILLES, MD | |
| CHU de Clermont-Ferrand | Not yet recruiting |
| Clermont-ferrand, France | |
| Sub-Investigator: Etienne GEOFFROY, MD | |
| CHU de Lille | Not yet recruiting |
| Lille, France | |
| Sub-Investigator: Annie POL, MD | |
| CHU de Limoges | Recruiting |
| Limoges, France | |
| Principal Investigator: Florence ROLLE, MD | |
| Hôpital Louis Pradel - CHU de Lyon | Recruiting |
| Lyon, France | |
| Sub-Investigator: Laurent SEBBAG, MD | |
| CHU de Nantes | Not yet recruiting |
| Nantes, France | |
| Sub-Investigator: T PETIT, MD | |
| Hôpital Européen Georges Pompidou | Recruiting |
| Paris, France | |
| Sub-Investigator: Romain GUILLEMAIN, MD | |
| Hôpital Pitié-Salpêtrière | Not yet recruiting |
| Paris, France | |
| Sub-Investigator: Shaida VARNOUS, MD | |
| CHU de Rennes | Not yet recruiting |
| Rennes, France | |
| Sub-Investigator: Bernard LELONG, MD | |
| CHU de Rouen | Recruiting |
| Rouen, France | |
| Sub-Investigator: Michel REDONNET, MD | |
| CHU de Strasbourg | Not yet recruiting |
| Strasbourg, France | |
| Sub-Investigator: Eric EPAILLY, MD | |
| CHU de NANCY | Not yet recruiting |
| Vandoeuvre Les Nancy, France | |
| Sub-Investigator: Marie Françoise MATTEI, MD | |
Sponsors and Collaborators
University Hospital, Limoges
Investigators
| Principal Investigator: | Pierre MARQUET, MD | University Hospital, Limoges |
More Information
No publications provided
| Responsible Party: | Mrs Marie SENGELEN, Directrice des Affaires médicales et de la Recherhce Clinique par intérim |
| ClinicalTrials.gov Identifier: | NCT00812786 History of Changes |
| Other Study ID Numbers: | 2006-006832-23 |
| Study First Received: | December 19, 2008 |
| Last Updated: | December 30, 2008 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Limoges:
|
heart transplantation immunosuppressive drugs individual dose adjustment harmacokinetics modelling |
Additional relevant MeSH terms:
|
Cyclosporins Cyclosporine Mycophenolic Acid Immunosuppressive Agents Mycophenolate mofetil Everolimus Sirolimus Tacrolimus Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Antibiotics, Antineoplastic Antineoplastic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013