Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
Phase 2
Completed
- Conditions
- Renal Transplantation
- Registration Number
- NCT00239798
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method Withdrawal of consent, death, or lost to follow up at Month 24 and Month 36 post-transplant 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 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