Status:
UNKNOWN
Effects of the Quadruple Immunosuppression on Peripheral Blood Lymphocytes and Development of Anti-HLA Antibodies in Kidney Transplant
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the effects of sirolimus in the phenotype of peripheral blood T and B lymphocytes regarding their naïve, memory, effector end regulatory phenotype and in the ...
Eligibility Criteria
Inclusion
- Men and women, ages 18 to 60 years inclusive
- Percentage of Panel Reactive Antibodies at transplantation \> 20%
- Estimated glomerular filtration rate using MDRD formula at inclusion \>29ml/min
Exclusion
- Subjects with a history of cancer
- Subjects with a previous non kidney transplantation
- Subjects receiving any immunosuppression different of tacrolimus/prednisone/mycophenolate
- Subjects with a urinary protein/creatinine ratio greater than 0.3
- Subjects with active HBV, HCV and HIV infection
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2017
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02208791
Start Date
July 1 2014
End Date
July 1 2017
Last Update
December 16 2015
Active Locations (1)
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1
Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil, 05403-900