The Role of B Cells in Kidney Allograft Dysfunction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Loma Linda University
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Blood collection prior to and after kidney transplantation
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Years to 85 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Kidney Transplant
Patients who are about to undergo a kidney transplant and are on immunosuppressive agents.
Intervention: Immunosuppressive Agents (Drug)
Outcomes
Primary Outcomes
Blood collection prior to and after kidney transplantation
Time Frame: 1,3,6,12,18,24,36,48, and 60 months
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).
Secondary Outcomes
- B cell count(Up to 60 months)