Trials / Completed
CompletedNCT03468478
Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation
Comparison of the Efficacy and Safety of Sirolimus, Everolimus or Mycophenolate in Renal Transplant Recipients Receiving Induction With Anti-thymocyte Globulin, Tacrolimus and Prednisone
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,209 (actual)
- Sponsor
- Hospital do Rim e Hipertensão · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sirolimus | sirolimus combined to reduced dose of tacrolimus |
| DRUG | Everolimus | everolimus combined to reduced dose of tacrolimus |
| DRUG | Mycophenolic acid | Control arm: mycophenolate combined to regular tacrolimus |
Timeline
- Start date
- 2017-06-18
- Primary completion
- 2021-03-18
- Completion
- 2021-08-23
- First posted
- 2018-03-16
- Last updated
- 2023-04-24
- Results posted
- 2023-04-24
Locations
1 site across 1 country: Brazil
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03468478. Inclusion in this directory is not an endorsement.