Renal Transplantation
Conditions
Keywords
Transplantation, kidney, and organ transplant.
Brief summary
This study will evaluate the long term 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
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Inclusion criteria
* Patients who completed the 12 month core study * Patients who gave written informed consent to participate in the study
Exclusion criteria
* Not applicable Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36 | — |
| Absolute lymphocyte count at Months 18, 24, 30 and 36. | — |
| IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant | — |
| Permanent resumption of dialysis within 36 months post transplant | — |
| Surgical removal of graft within 36 months post transplant | — |
| Death within 36 months post transplant | — |
| Withdrawal of consent, death, or lost to follow up within 36 months post transplant | — |
| Serum creatinine, calculated creatinine clearance and urine-protein/creatinine ratio at Months 18, 24, 30 and 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical examinations at Months 18, 24, 30 and 36 | — |
| Vital signs at Months 18, 24, 30 and 36 | — |
| Electrocardiogram at Months 24 and 36 | — |
| Chest X-ray Months 24 and 36 | — |
| Safety laboratory tests 18, 24, 30 and 36 | — |
| Ophthalmic evaluations 18, 24, 30 and 36 | — |
| AEs and SAEs | — |
| FTY720/CsA levels at Months 18, 24, 30 and 36 | — |
Outcome results
None listed