Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation (SEM)
Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation (SEM)
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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of the Efficacy and Safety of Sirolimus, Everolimus or Mycophenolate in Renal Transplant Recipients Receiving Induction With Anti-thymocyte Globulin, Tacrolimus and Prednisone
Actual Study Start Date: June 18, 2017
Estimated Primary Completion Date: June 18, 2020
Estimated Study Completion Date: June 18, 2021
Arm:
- Experimental: sirolimus +tacrolimus
- Experimental: everolimus +tacrolimus
- Active Comparator: mycophenolate +tacrolimus
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 400 |
| Study start date | 18 June 2017 |
| Estimated primary completion date | 18 June 2021 |