Efficacy of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients

Phase 4RecruitingNCT06584773

University of Sao Paulo General Hospital80 enrolled

Overview

In this study, sensitized renal transplant recipients, who present an increased risk of acute rejection, will be evaluated for the benefit of quadruple immunosuppression, adding sirolimus to the traditional scheme with tacrolimus, mycophenolate, and prednisone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

EverolimusDRUG

mTORi added as the fourth maintenance immunosuppressive drug in recipients

standard maintenance immunosuppressionDRUG

standard maintenance immunosuppression: tacrolimus, mycophenolate, prednisone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Sensitezed renal transplant recipients with reactivity panel of antibodies (PRA) greater than 30% who agree and sign the consent form. Exclusion Criteria: * Obese patients (body mass index above 35 m2); * History of GESF or membranoproliferative glomerulonephritis (MPGN) as primary cause of renal failure; * Proteinuria (protein/creatinine ratio) greater than 0.5 mg/dL at the time of initiation of Sirolimus; * Triglyceride levels greater than 300 mg/dl at enrollment; * Active infection by hepatitis B virus, hepatitis C virus or HIV; * CMV nonreactive IgG sorology at the time of transplantation.

Locations (1)

Renal Transplantation Service

São Paulo, Brazil

RECRUITING

Outcomes

Primary Outcomes

Occurrence of acute rejection and/or positive viremia for CMV

First occurrence of acute rejection and/or positive viremia for CMV, triggering early treatment within the first year after transplantation in sensitized patients.

Time frame: From enrollment to the end of treatment at 52 weeks

Data from ClinicalTrials.gov

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