Kidney Transplantation
Conditions
Keywords
Kidney, immunosuppression, transplant, rejection
Brief summary
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
Interventions
DRUGFTY 720
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Inclusion criteria
* Male and Female * Between 18 to 65 years old
Exclusion criteria
* Patients in need of multiple organ transplants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety/tolerability based on adverse event reporting. | — |
| BPAR, graft loss, death and study discontinuation, within 6 and 12 months post transplantation. | — |
| Efficacy parameters between the 3 treatment groups within 6 and 12 months post-transplantation. | — |
Countries
United States
Outcome results
None listed