drugset / Trial / NCT01028092
mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation
Phase 3
Completed
327 enrolled
University Hospital, Brest
Genzyme, a Sanofi Company · collabMinistry of Health, France · collabNovartis · collabRoche Pharma AG · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for elderly (\>60 years old) recipients receiving graft from elderly donor(\>60 years old).
Timeline
- Start
- 2009-03
- Primary completion
- 2014-03
- Completion
- 2014-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Basiliximab | Monoclonal antibody | 20 mg | — |
| Comparator | Cyclosporine | Peptide | 6 mg/kg | — |
| Comparator | Cyclosporine | Peptide | 8 mg/kg | — |
| Subject | Everolimus | Small molecule | 4 mg | — |
| Subject | Everolimus | Small molecule | 6 mg | — |
| Subject | Thymoglobulin | Protein / enzyme biologic | 1.5 mg/kg | — |
| Comparator | Mycophenolate Mofetil | Small molecule | 3 g | — |
Indications
No indication recorded.