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Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections

Primary Purpose

Viremia, Bacteremia, Acute Rejection of Renal Transplant

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
IVIG
Sponsored by
Shanghai Changzheng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Viremia focused on measuring IVIG Infection

Eligibility Criteria

6 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Any person approved as a transplant donor with recipient who has never undergone a previous transplantation Transplant donor must be 6 years old or older They must have provided signed informed consent The donors must be willing to contribute samples of blood Exclusion Criteria: Any potential transplant donor who is receiving or have received anti-herpes medication in the past week Any potential transplant donor to a recipient who has received a previous solid organ transplant Any potential transplant donor who is immunosuppressed due to medical disease and/or immunosuppressive or immunomodulating medications Any potential transplant donor who is on corticosteroids

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    IVIG

    Sham

    Arm Description

    Outcomes

    Primary Outcome Measures

    Next-Generation Sequencing (NGS) Results of Bacteremia or Viremia in Transplant Recipient
    NGS is a technology for determining the sequence of DNA or RNA to study genetic variation associated with diseases like bacteremia and viremia.
    Incidence of Bacteremia or Viremia in Transplant Recipient

    Secondary Outcome Measures

    Incidence of Acute Rejection in Transplant Recipient

    Full Information

    First Posted
    March 13, 2023
    Last Updated
    April 3, 2023
    Sponsor
    Shanghai Changzheng Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05799716
    Brief Title
    Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections
    Official Title
    Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Changzheng Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to learn about the benefit of IVIG in donor-derived infections and the potential immunomodulatory effect on transplanted organs. The main questions it aims to answer are: How effective IVIG is in preventing donor-derived infections Does IVIG has potential immunomodulatory effect on transplanted organs
    Detailed Description
    Donor-derived infections are defined as any infection present in the donor that is transmitted to one or more recipient. Donor-derived infections can be categorized into two groups: "expected" and "unexpected" infections. Expected transmissions occur when the donor is known to have an infection, as demonstrated by positive serology or nucleic acid test (NAT) result for cytomegalovirus (CMV), Epstein-Barr virus (EBV) or hepatitis B and C, or positive cultures in the donor at the time of donation. Unexpected transmissions may occur despite current screening strategies and are not expected in the donor at the time of organ placement. Intravenous immunoglobulins (IVIG) are produced by pooling together of serum immunoglobulins from multiple donors, and are known to have powerful immunomodulatory and anti-inflammatory functions in vitro and in vivo. The goal of this study is to figure out the benefit of IVIG in donor-derived infections and the potential immunomodulatory effect on transplanted organs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Viremia, Bacteremia, Acute Rejection of Renal Transplant
    Keywords
    IVIG Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IVIG
    Arm Type
    Experimental
    Arm Title
    Sham
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    IVIG
    Intervention Description
    0.5g/Kg
    Primary Outcome Measure Information:
    Title
    Next-Generation Sequencing (NGS) Results of Bacteremia or Viremia in Transplant Recipient
    Description
    NGS is a technology for determining the sequence of DNA or RNA to study genetic variation associated with diseases like bacteremia and viremia.
    Time Frame
    14 days
    Title
    Incidence of Bacteremia or Viremia in Transplant Recipient
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    Incidence of Acute Rejection in Transplant Recipient
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Any person approved as a transplant donor with recipient who has never undergone a previous transplantation Transplant donor must be 6 years old or older They must have provided signed informed consent The donors must be willing to contribute samples of blood Exclusion Criteria: Any potential transplant donor who is receiving or have received anti-herpes medication in the past week Any potential transplant donor to a recipient who has received a previous solid organ transplant Any potential transplant donor who is immunosuppressed due to medical disease and/or immunosuppressive or immunomodulating medications Any potential transplant donor who is on corticosteroids
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jinghui Yang
    Phone
    021-81885756
    Email
    yjh@smmu.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections

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