The Role of B Cells in Kidney Allograft Dysfunction

Completed

• Conditions: Kidney; Complications, Allograft; Transplantation Infection
• Interventions: Drug: Immunosuppressive Agents

• Registration Number: NCT02294032
• Lead Sponsor: Loma Linda University

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 Timeline

• Study First Submitted: 2014-05-29
• Study Start: 2014-08-28
• Study First Submitted QC: 2014-11-14
• Study First Posted: 2014-11-19
• Primary Completion: 2023-04-24
• Study Completion: 2023-04-24
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-18
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney Transplant	Immunosuppressive Agents	Patients who are about to undergo a kidney transplant and are on immunosuppressive agents.

Primary Outcome Measures

Name	Time	Method
Blood collection prior to and after kidney transplantation	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 Outcome Measures

Name	Time	Method
B cell count	Up to 60 months	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.

Trial Locations

Locations (1)

Loma Linda University Medical Center, Transplantation Institute; 🇺🇸 Loma Linda, California, United States