drugset / Trial / NCT00332839
Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.
RandomizedParallel-groupOpen-labelPrevention
Summary
Calcineurin inhibitors (CNI), a potent immunosuppressive drug used in kidney transplant recipients to prevent graft rejection, may cause renal impairment. The aim of this study is to assess whether a CNI-free regimen with enteric-coated mycophenolate sodium and everolimus is as safe and well tolerated as a standard regimen consisting of enteric-coated mycophenolate sodium and cyclosporine microemulsion without a compromise in therapeutic efficacy while resulting in an improved renal function.
Timeline
- Start
- 2005-11
- Primary completion
- 2013-03
- Completion
- 2013-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclosporine | Peptide | — | — |
| Subject | Everolimus | Small molecule | — | — |
| Comparator | Tacrolimus | Small molecule | — | — |
| Background | mycophenolic acid | Small molecule | 720 mg | — |
Indications
No indication recorded.