drugset / Trial / NCT01802268
Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients
RandomizedParallel-groupOpen-labelTreatment
Summary
Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate long-term CNi associated adverse events. This study aims to evaluate the conversion from tacrolimus to sirolimus in de novo kidney transplant recipients. This multicenter, open-label study, planned to enroll 297 patients initially treated with tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The primary objective is to show superior glomerular filtration rate in the SRL group at 24 months after transplantation.
Timeline
- Start
- 2008-02
- Primary completion
- 2012-04
- Completion
- 2012-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sirolimus | Small molecule | — | — |
| Comparator | Tacrolimus | Small molecule | — | — |
Indications
No indication recorded.