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Completed

NCT Number: NCT02294032

The Role of B Cells in Kidney Allograft Dysfunction

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.

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Key information

Age range

2 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University Medical Center, Transplantation Institute

Loma Linda, California, 92354, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunosuppressive Agents

Drug

standard of care for patients post-transplant

Other names: Prograf, Cellcept

Primary outcomes

  1. 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

  1. B cell count

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2014
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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