Effects of the Quadruple Immunosuppression on Peripheral Blood Lymphocytes and Development of Anti-HLA Antibodies in Kidney Transplant

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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 development of anti-HLA antibodies among kidney transplant recipients with high immunological risk for graft rejection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Treatments: Antibodies; Everolimus; Prednisone; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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