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This study will evaluate the long term safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FTY720 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ||
| 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. |
| Measure | Description | 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 |
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Inclusion Criteria
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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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| 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 |
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |