Renal Transplantation
Conditions
Keywords
Transplantation, kidney, and organ transplant
Brief summary
This study will evaluate the safety and efficacy of FTY720 combined with tacrolimus and corticosteroids in patients receiving a kidney 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
* Completed the 12 month core study * Informed consent
Exclusion criteria
* N/A Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute lymphocyte count at Month 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, estimated creatinine clearance, assessment of other laboratory abnormalities and vital signs and measurement of urine protein. at Months 18, 24, 30 and 36 | — |
| Pulmonary FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% 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