Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant
Phase 3
Completed
- Conditions
- Kidney Transplantation
- Interventions
- Drug: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroidsDrug: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
- Registration Number
- NCT00099736
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 696
Inclusion Criteria
- First kidney transplantation
- Male and female patients
- Between 18 and 65 years old
Exclusion Criteria
- Patients in need of multiple organ transplants
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids, FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids - FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids - MMF 2 g + full-dose Neoral (FDN) + corticosteroids MMF 2 g + full-dose Neoral (FDN) + corticosteroids -
- Primary Outcome Measures
Name Time Method death within 12 months post transplant withdrawal of consent, death, or lost to follow up within 12 months post transplant surgical removal of graft within 12 months post transplant IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant permanent resumption of dialysis within 12 months post transplant
- Secondary Outcome Measures
Name Time Method absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12 FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12 cystatin C at months 3, 6, and 12 serum creatinine proteinuria at day 28, months 6 and 12