Phase 4
Completed N=1,209
Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation
Kidney Transplant Infection
Source: ClinicalTrials.gov NCT03468478 ↗
Enrolled (actual)
1,209
Serious AEs
60.5%
Results posted
Apr 2023
Primary outcomePrimary: Incidence of Cytomegalovirus Infection or Disease — 9; 7; 39 Participants
◆ Published Evidence
Emerging
10citations · ~5 / year
A Head-to-head Comparison of De Novo Sirolimus or Everolimus Plus Reduced-dose Tacrolimus in Kidney Transplant Recipients: A Prospective and Randomized Trial.
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.
Linked Publications
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A Head-to-head Comparison of De Novo Sirolimus or Everolimus Plus Reduced-dose Tacrolimus in Kidney Transplant Recipients: A Prospective and Randomized Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Cytomegalovirus Infection or Disease |
9; 7; 39 | — |
Eligibility Criteria
Inclusion Criteria
- Recipients, adults of the first living or deceased donor kidney transplant;
- Patients who agreed to participate in the study and signed the informed consent form
Exclusion Criteria
- Receptors with a medical history of nephrotic syndrome or focal and segmental glomerulosclerosis confirmed as the etiology of end-stage renal disease;
- Receptors with poor understanding about chronic kidney disease and its treatment alternatives;
- Receptors with early history of non compliance to treatment with immunosuppressive drugs;
- Retransplantation;
- Multi-organ recipients;
- Recipients with BMI> 30 kg / m2;
- KDPI> 80%;
- Cold ischemia time greater than 24 hours;
- Receptors with a percentage of anti-HLA antibodies above 50%, either class I or Class II;
- Women of childbearing potential who do not undertake contraceptive methods (condoms or oral contraceptives).
- Patients receiving immunosuppressive therapy prior to transplantation, except low dose of prednisone;
- Patients with severe uncontrolled dyslipidemia;
- Patients who have a known contraindication for administration of any of the immunosuppressive drugs provided for in this study;
Data sourced from ClinicalTrials.gov (NCT03468478) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.