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

University of Sao Paulo General Hospital

Status and phase: Enrolling; Phase 4

Conditions: Disorder Related to Renal Transplantation

Treatments: Drug: standard maintenance immunosuppression; Drug: Everolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT06584773

CAAE40606115.6.000.0068

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

standard maintenance immunosuppression

Active Comparator group

Description:

tacrolimus, mycophenolate and prednisone

Treatment:

Drug: standard maintenance immunosuppression

fourth maintenance immunosuppressive

Experimental group

Description:

everolimus, tacrolimus, mycophenolate and prednisone

Treatment:

Drug: Everolimus