Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections

• Sponsor: Shanghai Changzheng Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05799716
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 17.1

Study Details

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:

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

2. Does IVIG has potential immunomodulatory effect on transplanted organs

Condition or Disease	Intervention/Treatment	Phase
Viremia; Bacteremia; Acute Rejection of Renal Transplant	Drug: IVIG	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IVIG	Drug: IVIG; 0.5g/Kg
No Intervention: Sham

Outcome Measures

Primary Outcome Measures

1. Next-Generation Sequencing (NGS) Results of Bacteremia or Viremia in Transplant Recipient [14 days]

   NGS is a technology for determining the sequence of DNA or RNA to study genetic variation associated with diseases like bacteremia and viremia.

2. Incidence of Bacteremia or Viremia in Transplant Recipient [14 days]

Secondary Outcome Measures

1. Incidence of Acute Rejection in Transplant Recipient [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai Changzheng Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Changzheng Hospital
• ClinicalTrials.gov Identifier: NCT05799716
• Other Study ID Numbers: CT20230313
• First Posted: Apr 5, 2023
• Last Update Posted: Apr 5, 2023
• Last Verified: Mar 1, 2023

• 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 Shanghai Changzheng Hospital: IVIG Infection
• Additional relevant MeSH terms: Infections; Bacteremia; Viremia

Study Results

No Results Posted as of Apr 5, 2023