The Role of B Cells in Kidney Allograft Dysfunction

Loma Linda University (LLU)

Status: Completed

Conditions: Transplantation Infection; Kidney; Complications, Allograft

Treatments: Drug: Immunosuppressive Agents

Study type: Observational

Funder types: Other

Identifiers

NCT02294032

GCAT 2014 (Other Grant/Funding Number)

5140147

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 2 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

180 participants in 1 patient group

Kidney Transplant

Description:

Patients who are about to undergo a kidney transplant and are on immunosuppressive agents.

Treatment:

Drug: Immunosuppressive Agents