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This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FTY720 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| IA, IB, IIA, IIB or III 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 | ||
| Discontinuation within 36 months post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 , FVC, DLCO within 36 months post transplant | ||
| Serum creatinine and estimated creatinine clearance within 36 months post transplant | ||
| Absolute lymphocyte count within 36 months post transplant |
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Inclusion Criteria
- Completion of Core study
Exclusion Criteria
Other protocol-defined exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |