De novo kidney transplantation
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) The patient has given written informed consent to participate in the extension study. b) The patient has completed the Month 12 visit of the core study either on or off study medication. c) Females capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s). 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Not applicable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: The secondary objectives are to provide long-term information under continued study medication beyond 12 months post transplantation on all other efficacy and safety parameters (as per original protocol). ;Primary end point(s): treated biopsy proven acute rejection, graft loss, death, or premature discontinuation from study | — |
Countries
Germany
Outcome results
None listed