drugset / Trial / NCT00862979
A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.
Timeline
- Start
- 2009-02-24
- Primary completion
- 2017-03-06
- Completion
- 2017-03-06
Outcome
Met primary endpoint
registry analysis (superiority test); CNI-regimen vs CNI-free-regimen; p <.0001; Mean Difference (Net) -11.3 (95% CI -16.5 to -6.1); ANCOVA NCT00862979 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclosporine | Peptide | 10 mg | — |
| Subject | Cyclosporine | Peptide | 25 mg | — |
| Subject | Cyclosporine | Peptide | 50 mg | — |
| Subject | Cyclosporine | Peptide | 100 mg | — |
| Subject | Enteric-coated mycophenolate sodium | Unknown | 180 mg | — |
| Subject | Enteric-coated mycophenolate sodium | Unknown | 360 mg | — |
| Subject | Everolimus | Small molecule | 0.25 mg | — |
| Subject | Everolimus | Small molecule | 0.75 mg | — |
| Subject | Everolimus | Small molecule | 1 mg | — |
| Subject | Mycophenolate Mofetil | Small molecule | 250 mg | — |
| Subject | Mycophenolate Mofetil | Small molecule | 500 mg | — |
| Subject | Tacrolimus | Small molecule | 0.5 mg | — |
| Subject | Tacrolimus | Small molecule | 1 mg | — |
| Subject | Tacrolimus | Small molecule | 5 mg | — |
| Background | Prednisolone | Other / unclassified | 0.05 mg/kg | — |
| Background | Prednisolone | Other / unclassified | 0.3 mg/kg | — |
Indications
No indication recorded.