Status:
RECRUITING
Efficacy of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
Carlucci G Ventura
Daniel R Salomon
Conditions:
Disorder Related to Renal Transplantation
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 tradi...
Eligibility Criteria
Inclusion
- Sensitezed renal transplant recipients with reactivity panel of antibodies (PRA) greater than 30% who agree and sign the consent form.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06584773
Start Date
June 1 2015
End Date
July 1 2025
Last Update
September 5 2024
Active Locations (1)
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1
Renal Transplantation Service
São Paulo, Brazil, 05403-900