Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
Phase 3
Completed
- Conditions
- Renal Transplantation
- Registration Number
- NCT00239785
- 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 organ transplant
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 684
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Death 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 Surgical removal of graft within 12 months post transplant Withdrawal of consent, death, or lost to follow up within 12 months post transplant
- Secondary Outcome Measures
Name Time Method FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12 Serum creatinine Cystatin C at months 3, 6, and 12 Proteinuria at day 28, months 6 and 12 Absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which FTY720 modulates T-cell trafficking in renal transplantation?
How does FTY720 compare to mycophenolate mofetil in reducing acute rejection rates when combined with cyclosporine and corticosteroids in de novo renal transplant recipients?
Which biomarkers correlate with improved graft survival in NCT00239785 FTY720-based immunosuppressive regimens?
What are the long-term adverse event profiles of FTY720 versus mycophenolate mofetil in renal transplant patients on cyclosporine and corticosteroids?
How do FTY720 and mycophenolate mofetil combination therapies with cyclosporine and corticosteroids influence CNI-related nephrotoxicity in renal transplantation?