Status:
COMPLETED
Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation
Lead Sponsor:
Hospital do Rim e Hipertensão
Conditions:
Kidney Transplant Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
June 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2021
Estimated Enrollment :
1209 Patients enrolled
Trial Details
Trial ID
NCT03468478
Start Date
June 18 2017
End Date
August 23 2021
Last Update
April 24 2023
Active Locations (1)
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1
Hospital do Rim
São Paulo, São Paulo, Brazil, 04038002