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

Phase 4

Completed

• Conditions: Kidney Transplant Infection
• Interventions: Drug: Everolimus; Drug: Sirolimus; Drug: Mycophenolic acid

• Registration Number: NCT03468478
• Lead Sponsor: Hospital do Rim e Hipertensão

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-18
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-16
• Primary Completion: 2021-03-18
• Study Completion: 2021-08-23
• Results First Submitted: 2022-11-04
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-20
• Last Update Submitted: 2023-04-20
• Results First Posted: 2023-04-24
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1209

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
everolimus +tacrolimus	Everolimus	Patients will receive initial dose of 0,05 mg/kg BID de tacrolimus to reach blood trough concentration between 3-5 ng/mL. Initial dose of 1.5 mg BID of everolimus to reach blood trough concentration between 4-8 ng/mL.
sirolimus +tacrolimus	Sirolimus	Patients will receive initial dose of 0,05 mg/kg BID oftacrolimus to reach blood trough concentration between 3-5 ng/mL. Initial dose of sirolimus of 3mg once a day to reach blood trough concentration between 4-8 ng/mL.
mycophenolate +tacrolimus	Mycophenolic acid	Patients will receive initial dose of 0,1 mg/kg BID de tacrolimusto reach blood trough concentration between Fixed dose of mycophenolate (mycophenolate mofetil, 1 g BID or sodium mycophenolate, 720 mg BID).

Primary Outcome Measures

Name	Time	Method
Incidence of Cytomegalovirus Infection or Disease	12 months follow up	Incidence of CMV infection/disease in three study groups (SRL, EVR anda MPS).

Trial Locations

Locations (1)

Hospital do Rim; 🇧🇷 São Paulo, Sao Paulo, Brazil