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

University of Sao Paulo General Hospital

Status and phase: Unknown; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: No intervention; Drug: Sirolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT02208791

U1111-1157-7462

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Tacrolimus/MPS/Prednisone

Active Comparator group

Description:

This arm will be maintained with current conventional triple immunosuppression. Sirolimus will not be added to this arm

Treatment:

Drug: No intervention

Sirolimus/Low Tacrolimus/MPS/Prednisone

Experimental group

Description:

Sirolimus, 2mg once daily, will be added to the maintenance immunosuppression composed of tacrolimus, prednisone and mycophenolate. The prescription of tacrolimus will be tapered down to achieve a peripheral blood trough level between 3 e 5 ng/mL and micophenolate will be reduced to 540mg bid..

Treatment:

Drug: Sirolimus