The Role of B Cells in Kidney Allograft Dysfunction

Study Overview
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Brief Summary
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The purpose of this study is to understand the role of specific B cells in activating or repressing an anti-allograft immune response after kidney transplantation. In this study, blood will be collected from kidney transplant patients during different timepoints, prior to and after their transplant. Knowledge gained from study findings will be used to develop therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of long-term graft loss in kidney transplant patients.

Detailed Description
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The purpose of this study is to understand the role of specific B cells in activating or repressing an anti-allograft immune responses after kidney transplantation. This study aims to address two major challenges in kidney transplantation: 1. to guide physicians when immunosuppressive drugs are weaned, and 2. to identify patients who are at risk or in the process of developing antibody-mediated rejection. In this study, blood will be collected from kidney transplant patients during different timepoints, prior to and after their transplant. Knowledge gained from study findings will be used to develop therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of long-term graft loss in kidney transplant patients.

Official Title
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The Role of B Cells in Kidney Allograft Dysfunction

Conditions
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Kidney; Complications, Allograft, Transplantation Infection

Intervention / Treatment
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* Drug: Immunosuppressive Agents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and willingness to sign the written informed consent form (ICF). For pediatric patients, a parent or legal guardian must sign ICF Either a Kidney or Liver transplant patient: 1) on the waitlist or 2) transplanted Healthy volunteer samples collected to use as the control group for statistical validity Exclusion Criteria: Inability to make all of the required long-term post-transplant visits. Females who are pregnant or nursing a child Liver patients with hepatitis C virus

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney Transplant<br>Patients who are about to undergo a kidney transplant and are on immunosuppressive agents. | Drug: Immunosuppressive Agents<br>* standard of care for patients post-transplant<br>* Other names: Prograf, Cellcept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood collection prior to and after kidney transplantation | Blood will be collected from kidney transplant patients prior to and after their transplant (1-, 3-, 6-, 12-, 18-, 24-, 36-, 48-, and 60- months post-transplant). We will try to better understand the role of specific B-cells after kidney transplant by using enzyme-linked immunosorbent assay (ELISA). | 1,3,6,12,18,24,36,48, and 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| B cell count | For each patient, we will be measuring the frequency of cells from each B cell subset within the total peripheral blood mononuclear cells (PBMNCs) by MACSQuant cell counts. The distribution of B cells subsets within the total B cell pool will also be determined. Mean Fluorescence Intensity (MFI) of activation markers (CD86 and CD69) on B cells will also be compared across the samples. | Up to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bcells, kidney allograft dysfunction, antibody mediated rejection