Status:
COMPLETED
Pharmacokinetics of Immunosuppressive Drugs in Heart Transplant Patients
Lead Sponsor:
University Hospital, Limoges
Conditions:
Heart Transplant
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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, takin...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00812786
Start Date
July 1 2007
End Date
May 1 2012
Last Update
July 30 2025
Active Locations (12)
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1
CHU de Bordeaux
Bordeaux, France
2
CHU de Clermont-Ferrand
Clermont-Ferrand, France
3
CHU de Lille
Lille, France
4
CHU de Limoges
Limoges, France