Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
Phase 3
Completed
- Conditions
- Renal Transplantation
- Registration Number
- NCT00239876
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will evaluate the safety and efficacy of FTY720 combined with tacrolimus and corticosteroids in patients receiving a kidney transplant
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
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 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, estimated creatinine clearance, assessment of other laboratory abnormalities and vital signs and measurement of urine protein. at Months 18, 24, 30 and 36 Pulmonary FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36 Absolute lymphocyte count at Month 18, 24, 30 and 36.
- Secondary Outcome Measures
Name Time Method Physical examinations at Months 18, 24, 30 and 36 Vital signs at Months 18, 24, 30 and 36 Electrocardiogram at Months 24 and 36 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