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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-18

Study Completion Date

2021-08-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Transplant Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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sirolimus +tacrolimus

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.

Group Type EXPERIMENTAL

Sirolimus

Intervention Type DRUG

sirolimus combined to reduced dose of tacrolimus

everolimus +tacrolimus

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.

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

everolimus combined to reduced dose of tacrolimus

mycophenolate +tacrolimus

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).

Group Type ACTIVE_COMPARATOR

Mycophenolic acid

Intervention Type DRUG

Control arm: mycophenolate combined to regular tacrolimus

Interventions

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Sirolimus

sirolimus combined to reduced dose of tacrolimus

Intervention Type DRUG

Everolimus

everolimus combined to reduced dose of tacrolimus

Intervention Type DRUG

Mycophenolic acid

Control arm: mycophenolate combined to regular tacrolimus

Intervention Type DRUG

Other Intervention Names

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Rapamune Certican mycophenolate sodium

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No