NCT05799716

Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	IVIG	0.5g/Kg

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-04-01
• Completion: 2024-09-01
• First posted: 2023-04-05
• Last updated: 2023-04-05