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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Effects of Sirolimus Addition to the Triple Immunosuppression Protocol on Peripheral Blood Lymphocytes and Development of Anti-HLA Antibodies in Sensitized Kidney Transplant Recipients - a Pilot Study

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Sirolimus
* Drug: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tacrolimus/MPS/Prednisone<br>This arm will be maintained with current conventional triple immunosuppression. Sirolimus will not be added to this arm | Drug: No intervention<br> <br> |
| Experimental: Sirolimus/Low Tacrolimus/MPS/Prednisone<br>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.. | Drug: Sirolimus<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite of graft loss and/or death with graft function |  | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with serious and non-serious adverse events and the incidence of biopsy proven acute allograft rejection |  | Up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Transplantation, Graft Rejection, Immunossupression