Efficacy of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
Efficacy and Impact on CMV Infection of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
University of Sao Paulo General Hospital
80 participants
Jun 1, 2015
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- Sensitezed renal transplant recipients with reactivity panel of antibodies (PRA) greater than 30% who agree and sign the consent form.
Exclusion Criteria6
- 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.
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Interventions
mTORi added as the fourth maintenance immunosuppressive drug in recipients
standard maintenance immunosuppression: tacrolimus, mycophenolate, prednisone
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06584773