Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections

Naval Military Medical University (Second Military Medical University)

Status and phase

Not yet enrolling

Phase 4

Conditions

Bacteremia

Acute Rejection of Renal Transplant

Viremia

Treatments

Drug: IVIG

Study type

Interventional

Funder types

Other

Identifiers

NCT05799716

CT20230313

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

6 to 65 years old

Volunteers

No 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