renal transplantation MedDRA version: 9.1 Level: LLT Classification code 10038533 Term: Renal transplant MedDRA version: 9.1 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection
Conditions
Interventions
Product Name: MYFORTIC®
Pharmaceutical Form: Cachet
Sponsors
CHU Saint-Etienne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - >18 years - Receveurs d’une greffe rénale à partir d'un donneur décédé ou vivant. - Renal transplant from a dead or alive donor. - Patients treated by initial quadritherapy with basiliximab, tacrolimus, stéroïdes et mycophénolate sodique - Test de grossesse ßHCG négatif à l’initiation du traitement Myfortic® - Contraception efficace pendant le traitement et jusqu’à 6 semaines après le traitement par Myfortic® Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patient at high risk of rejection of a transplant - IMC > ou = 30 - Platelets < 75000 / mm3 et/ou neutrophiles < 1500 / mm3 et/ou leucocytes < 2500/ mm3 et/ou hémoglobine < 6 g/dL. - Patient requiring a anti-CMV prophylaxis by valganciclovir. - Pregnant women or allaitantes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Describe the pharmacokinetics of the MYFORTIC ® ( MPA) with graded increased doses first 3 months of the renal transplantation;Secondary Objective: Determine the parameters of pharmacokinetic modelling of the MPA at renal transplanted patients treated by MYFORTIC ®.;Primary end point(s): Area under the curve (AUC0 - 12 hours) of the MPA and its métabolites MPAG and Ac-MPAG | — |
Countries
France
Outcome results
None listed