Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections

NCT05799716 | Unknown Phase 4

• 1 other identifier: CT20230313
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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. 1.How effective IVIG is in preventing donor-derived infections
2. 2.Does IVIG has potential immunomodulatory effect on transplanted organs

Conditions

Viremia; Bacteremia; Acute Rejection of Renal Transplant

Keywords

IVIG Infection

Outcome Measures

Primary Outcomes (2)

• 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.

  14 days

• Incidence of Bacteremia or Viremia in Transplant Recipient

  14 days

Secondary Outcomes (1)

• Incidence of Acute Rejection in Transplant Recipient

  1 month

Study Arms (2)

IVIG

EXPERIMENTAL

Drug: IVIG

Sham

NO INTERVENTION

Interventions

IVIG DRUG

0.5g/Kg

IVIG

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

MeSH Terms

Conditions

Viremia; Bacteremia

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Virus Diseases; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Jinghui Yang

CONTACT

021-81885756; yjh@smmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 5, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share