Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation

• Status: Completed
• Trial end date: 2021-08-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital do Rim e Hipertensão
• Treatments: Everolimus; Mycophenolic Acid; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

1. Recipients, adults of the first living or deceased donor kidney transplant;

2. Patients who agreed to participate in the study and signed the informed consent form

Exclusion Criteria:

1. Receptors with a medical history of nephrotic syndrome or focal and segmental glomerulosclerosis confirmed as the etiology of end-stage renal disease;

2. Receptors with poor understanding about chronic kidney disease and its treatment alternatives;

3. Receptors with early history of non compliance to treatment with immunosuppressive drugs;

4. Retransplantation;

5. Multi-organ recipients;

6. Recipients with BMI> 30 kg / m2;

7. KDPI> 80%;

8. Cold ischemia time greater than 24 hours;

9. Receptors with a percentage of anti-HLA antibodies above 50%, either class I or Class II;

10. Women of childbearing potential who do not undertake contraceptive methods (condoms or oral contraceptives).

11. Patients receiving immunosuppressive therapy prior to transplantation, except low dose of prednisone;

12. Patients with severe uncontrolled dyslipidemia;

13. Patients who have a known contraindication for administration of any of the immunosuppressive drugs provided for in this study;