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The Role of B Cells in Kidney Allograft Dysfunction

Sponsor
Loma Linda University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02294032
Collaborator
(none)
112
Enrollment
1
Location
129.1
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Immunosuppressive Agents

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 [Patient Registry]
Actual Enrollment :
112 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Role of B Cells in Kidney Allograft Dysfunction
Actual Study Start Date :
Aug 28, 2014
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Kidney Transplant

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

Drug: Immunosuppressive Agents
standard of care for patients post-transplant
Other Names:
  • Prograf, Cellcept

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 85 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Loma Linda University Medical Center, Transplantation Institute Loma Linda California United States 92354

    Sponsors and Collaborators

    • Loma Linda University

    Investigators

    • Principal Investigator: Michael de Vera, MD, FACS, Loma Linda University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Loma Linda University
    ClinicalTrials.gov Identifier:
    NCT02294032
    Other Study ID Numbers:
    • 5140147
    • GCAT 2014
    First Posted:
    Nov 19, 2014
    Last Update Posted:
    May 2, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Loma Linda University
    Bcells
    kidney allograft dysfunction
    antibody mediated rejection
    Additional relevant MeSH terms:
    Immunosuppressive Agents

    Study Results

    No Results Posted as of May 2, 2022