Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

Study Overview
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Brief Summary
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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.

Official Title
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A 24-month Extension of a One-year, Multicenter, Double Blinded Double Dummy, Randomized Study to Evaluate the Safety and Efficacy of Two Doses of FTY720 Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Steroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Steroids, in Adult de Novo Renal Transplant Recipients

Conditions
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Renal Transplantation

Intervention / Treatment
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* Drug: FTY720


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients who have completed the 12 Month visit of the Core trial either on or off study drug. Female capable of becoming pregnant are required to have a medically approved method of birth control until 3 Month after study medication was stopped. Exclusion Criteria - None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FTY720|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplantation, kidney, organ transplant