Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections

NCT ID: NCT05799716

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-09-01

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:

1. How effective IVIG is in preventing donor-derived infections

2. 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.

Conditions

Viremia; Bacteremia; Acute Rejection of Renal Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

IVIG

Group Type: EXPERIMENTAL

IVIG

Intervention Type: DRUG

0.5g/Kg

Sham

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

IVIG

0.5g/Kg

Intervention Type: DRUG

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Changzheng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jinghui Yang

Role: CONTACT

yjh@smmu.edu.cn

021-81885756

Other Identifiers

CT20230313

Identifier Type: -

Identifier Source: org_study_id