Renal Transplantation
Conditions
Keywords
Transplantation, kidney, and organ transplant.
Brief summary
This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant
Interventions
DRUGFTY720
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 patients of any race between 18 to 65 years old (inclusive) * Patients scheduled to undergo a primary cadaveric or primary non-HLA identical living donor kidney transplantation * Patients who gave written informed consent to participate in the study
Exclusion criteria
* Recipients of multi-organ transplantation or foreseen to receive a non-renal allograft during the study period * Graft cold ischemia time greater than 40 hours. * Patients with pulse rate \< 50 beats per minute (bpm) at screening Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Withdrawal of consent, death, or lost to follow up within 12 months post transplant | — |
| IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant | — |
| Permanent resumption of dialysis within 12 months post transplant | — |
| Surgical removal of graft within 12 months post transplant | — |
| Death within 12 months post transplant | — |
Secondary
| Measure | Time frame |
|---|---|
| FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12 | — |
| Serum creatinine | — |
| Cystatin C at months 3, 6, and 12 | — |
| Proteinuria at day 28, months 6 and 12 | — |
| Absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12 | — |
Outcome results
None listed