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Effects of A Standardized Treatment Approach on Kidney Transplant Recipients With Antibody-Mediated Rejection

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT04367610
Collaborator
(none)
75
Enrollment
1
Location
16
Actual Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Antibody-mediated rejection (ABMR) is one of the leading causes of graft loss in kidney transplant recipients (KTRs). Although it is a well characterized entity, there is limited data regarding effective treatment options for preserving graft functions. Moreover, results from different studies have been contradictory. Therefore, we conducted a study using our registry data to evaluate the effects of a standardized treatment approach consisting of therapeutic plasma exchange (regular plasmapheresis, double filtration plasmapheresis or immunoadsorption), intravenous immunoglobulin and rituximab on KTRs with acute or chronic ABMR.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    75 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Effects of A Standardized Treatment Approach Comprising Plasma Exchange, Intravenous Immunoglobulin and Rituximab on Kidney Transplant Recipients With Acute or Chronic Antibody-Mediated Rejection
    Actual Study Start Date :
    Sep 1, 2019
    Actual Primary Completion Date :
    Aug 31, 2020
    Actual Study Completion Date :
    Dec 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Study Group

    Kidney transplant recipients with biopsy-proven acute or chronic antibody-mediated rejection who were treated using 6 sessions of therapeutic plasma exchange, 2 g/kg of intravenous immunoglobulin and 1-2 weekly doses of 375 mg/m2 rituximab.

    Outcome Measures

    Primary Outcome Measures

    1. Graft Loss [2-5 years]

      Returning to dialysis due to graft failure or death with a functioning graft.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Being a kidney transplant recipient with biopsy-proven acute or chronic antibody-mediated rejection who were treated using 6 sessions of therapeutic plasma exchange, 2 g/kg of intravenous immunoglobulin and 1-2 weekly doses of 375 mg/m2 rituximab.
    Exclusion Criteria:
    • Not providing or withdrawing consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul University Istanbul Turkey

    Sponsors and Collaborators

    • Istanbul University

    Investigators

    • Study Chair: Halil Yazici, MD, Department of Internal Medicine, Istanbul Faculty of Medicine
    • Principal Investigator: Safak Mirioglu, MD, Department of Internal Medicine, Istanbul Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Safak Mirioglu, Principal Investigator, Istanbul University
    ClinicalTrials.gov Identifier:
    NCT04367610
    Other Study ID Numbers:
    • 2019/976
    First Posted:
    Apr 29, 2020
    Last Update Posted:
    May 18, 2021
    Last Verified:
    May 1, 2021
    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 Safak Mirioglu, Principal Investigator, Istanbul University
    antibody-mediated rejection
    kidney transplantation

    Study Results

    No Results Posted as of May 18, 2021