drugset / Trial / NCT03468478
Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation
RandomizedParallel-groupOpen-labelPrevention
Summary
This study was designed to compare 3 immunosuppression regimens: sirolimus and tacrolimus versus everolimus and tacrolimus versus mycophenolate and tacrolimus. The primary outcome is the incidence of cytomegalovirus infection / disease, a relevant medical need in the absence of pharmacological prophylaxis.
Timeline
- Start
- 2017-06-18
- Primary completion
- 2021-03-18
- Completion
- 2021-08-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 1.5 mg | — |
| Subject | Sirolimus | Small molecule | 3 mg | — |
| Comparator | mycophenolic acid | Small molecule | 720 mg | — |
| Comparator | mycophenolic acid | Small molecule | 1 g | — |