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

Kidney Transplant Infection Clinical Trial

— SEM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03468478
• Other study ID #: HRHipertensao
• Status: Completed
• Phase: Phase 4
• Start date: June 18, 2017
• Est. completion date: August 23, 2021

Study information

• Verified date: April 2023
• Source: Hospital do Rim e Hipertensão
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1209
• Est. completion date: August 23, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Kidney Transplant Infection

Intervention

Drug:
• Sirolimus
sirolimus combined to reduced dose of tacrolimus
• Everolimus
everolimus combined to reduced dose of tacrolimus
• Mycophenolic acid
Control arm: mycophenolate combined to regular tacrolimus

Locations

Country	Name	City	State
Brazil	Hospital do Rim	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Rim e Hipertensão

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Cytomegalovirus Infection or Disease	Incidence of CMV infection/disease in three study groups (SRL, EVR anda MPS).	12 months follow up