Actively Recruiting
Efficacy of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
Led by University of Sao Paulo General Hospital · Updated on 2024-09-05
80
Participants Needed
1
Research Sites
526 weeks
Total Duration
On this page
Sponsors
U
University of Sao Paulo General Hospital
Lead Sponsor
C
Carlucci G Ventura
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Efficacy of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sensitized renal transplant recipients with panel reactive antibodies (PRA) greater than 30%
- Agreement to participate and signing of informed consent form
You will not qualify if you...
- Body mass index above 35 m2
- History of focal segmental glomerulosclerosis (FSGS) or membranoproliferative glomerulonephritis (MPGN) as primary cause of renal failure
- Proteinuria with protein/creatinine ratio greater than 0.5 mg/dL at start of sirolimus treatment
- Triglyceride levels above 300 mg/dL at enrollment
- Active infection with hepatitis B virus, hepatitis C virus, or HIV
- CMV IgG serology negative at the time of transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Renal Transplantation Service
São Paulo, Brazil, 05403-900
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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