Treating Donors With Intravenous Immunoglobulin to Reduce... | NCT05799716

Studies
Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections

NCT05799716

Sponsor

Shanghai Changzheng Hospital

Status

Unknown status

Last Update Posted

Apr 5, 2023Actual

Enrollment

40Estimated

Phase

Phase 4

Conditions

Viremia
Bacteremia
Acute Rejection of Renal Transplant

Interventions

IVIG

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Estimated

Primary Completion Date

Apr 1, 2024Estimated

Completion Date

Sep 1, 2024Estimated

First Submitted Date

Mar 13, 2023

First Submission Date that Met QC Criteria

Apr 3, 2023

First Posted Date

Apr 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2023

Last Update Posted Date

Apr 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

How effective IVIG is in preventing donor-derived infections
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IVIG	Experimental		Drug: IVIG
Sham	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IVIG	Drug	0.5g/Kg	IVIG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Incidence of Acute Rejection in Transplant Recipient		1 month

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jinghui Yang	Contact	021-81885756		yjh@smmu.edu.cn

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014766	Viremia
D016470	Bacteremia

Ancestor Terms

ID	Term
D014777	Virus Diseases
D007239	Infections
D018805	Sepsis
D018746	Systemic Inflammatory Response Syndrome

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016756	Immunoglobulins, Intravenous

Ancestor Terms

ID	Term
D007074	Immunoglobulin G
D007132	Immunoglobulin Isotypes
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided