A two-year extension to a one-year, multicenter, open-label, randomized study to evaluate the safety and efficacy of FTY720 combined with tacrolimus and steroids versus MMF (Cellcept) combined with tacrolimus and steroids, in de novo adult renal transplant recipients

Femme et Homme

| Pays :
| Organes :
| Spécialités :

Extrait

The objective of this extension is to assess long term efficacy and safety of FTY720 combined with corticosteroids and tacrolimus versus MMF combined with corticosteroids and tacrolimus in de novo adult renal transplant recipients beyond 12 months post-transplantation and to provide continued treatment for patients who have completed the 12-month core study on study medication. The key efficacy parameter is the incidence over the 36 months of the composite end-point of treated biopsy proven acute rejection, graft loss, death, or premature discontinuation from study. The key safety parameters include renal, cardiac and pulmonary function, infections and malignancies.

Critère d'inclusion

De Novo Kidney Transplantation

Liens

ictrp
euctr

Kusajili – Centralise les essais cliniques mondiaux

A two-year extension to a one-year, multicenter, open-label, randomized study to evaluate the safety and efficacy of FTY720 combined with tacrolimus and steroids versus MMF (Cellcept) combined with ta...