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FTY720 in kidney transplant
NCT00099749Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2003
- Primary completion
- Apr 2006
- Countries
- 1
- Sponsor
- Novartis
- Modality
- Small Molecules
- Drugs
- fingolimod
- Conditions
- kidney transplantation
01
Overview
Phase 3, randomised, double-blind trial of fingolimod in kidney transplantation (3 arms), sponsored by Novartis. Primary endpoint: Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation at 6 months. Started Nov 2003; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
FTY720 2.5 mg
Fingolimod 2.5 mg daily + Cyclosporine + Corticosteroids
FTY720 5.0 mg
Fingolimod 5.0 mg daily + Cyclosporine + Corticosteroids
Mycophenolate Mofetil
MMF 2 g daily + Cyclosporine + Corticosteroids
03
Endpoints
Primary
Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation
Secondary
Safety and tolerability based on adverse event reporting
Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation
Efficacy parameters between the 3 treatment groups
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