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| Name | Class |
|---|---|
| Tanabe Pharma Corporation | INDUSTRY |
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, III, or humoral acute 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, and estimated creatinine clearance within 36 months post transplant | ||
| FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% within 36 months post transplant | ||
| Absolute lymphocyte count within 36 months post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria at Month 24 and Month 36 post-transplant | ||
| Permanent resumption of dialysis at Month 24 and Month 36 post-transplant |
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Inclusion Criteria
Exclusion Criteria
- None
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17984842 | Result | Tedesco-Silva H, Szakaly P, Shoker A, Sommerer C, Yoshimura N, Schena FP, Cremer M, Hmissi A, Mayer H, Lang P; FTY720 2218 Clinical Study Group. FTY720 versus mycophenolate mofetil in de novo renal transplantation: six-month results of a double-blind study. Transplantation. 2007 Oct 15;84(7):885-92. doi: 10.1097/01.tp.0000281385.26500.3b. |
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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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| Surgical removal of graft at Month 24 and Month 36 post-transplant |
| Death at Month 24 and Month 36 post-transplant |
| Withdrawal of consent, death, or lost to follow up at Month 24 and Month 36 post-transplant |
| Serum creatinine, and estimated creatinine clearance at Month 24 and Month 36 post-transplant |
| FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Month 24 and Month 36 post-transplant |
| Absolute lymphocyte count at Month 18, 24, 30 and 36 |
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |