Status:
COMPLETED
Pharmacokinetic Evaluation of an Intensified and Decreasing Dosing Regimen of Mycophenolate Sodium in Combination With Tacrolimus Post Kidney Transplant: The Myfortic Study
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Mycophenolate acid (MPA) has been developed and approved in combination with cyclosporine and has been used in kidney transplantation for more than a decade. At present, combination of tacrolimus and ...
Eligibility Criteria
Inclusion
- \>18 years
- Renal transplant from a dead or alive donor.
- Patients treated by initial quadritherapy with basiliximab, tacrolimus, steroid et mycophenolate sodic
- ΒHCG pregnancy test negative at the initiation of Myfortic ®
- Effective contraception during treatment and up to 6 weeks after treatment with Myfortic ®
Exclusion
- Patient at high risk of rejection of a transplant
- IMC \> ou = 30
- Platelets \< 75000 / mm3 and/or neutrophils \< 1500 / mm3 and/or leukocytes \< 2500/ mm3 and/or hemoglobin \< 6 g/dL.
- Patient requiring a anti-CMV prophylaxis by valganciclovir.
- Pregnancy or breast feeding.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00941824
Start Date
February 1 2009
End Date
March 1 2010
Last Update
March 25 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Departement of Nephrology CHU Saint-Etienne
Saint-Etienne, France, 42055