ViremiaPhase 4NCT05799716
Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections
A Phase 4 study testing IVIG in people with Viremia and Bacteremia, run by Shanghai Changzheng Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Viremia, Bacteremia, Acute Rejection of Renal Transplant
- What is being tested?
- IVIG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the 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
- Being tested
- IVIG
- Keywords
- IVIG Infection
- Medical subject headings
- Viremia, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIGDrug
0.5g/Kg
| Study group | Role | What they receive |
|---|---|---|
| IVIG | Experimental | Not described Receives: Drug: IVIG |
| Sham | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Incidence of Bacteremia or Viremia in Transplant Recipient
Measured: 14 days
Secondary outcomes (1)
Incidence of Acute Rejection in Transplant Recipient
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799716
- Sponsor's protocol ID
- CT20230313
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections
- ClinicalTrials.gov ID
- NCT05799716
- Acronym / sponsor ID
- CT20230313
- Conditions
- Viremia, Bacteremia, Acute Rejection of Renal Transplant
- Keywords
- IVIG Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVIG | Experimental | Drug: IVIG |
| Sham | No intervention | – |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVIG0.5g/Kg | Drug | IVIG |
Primary outcome
Next-Generation Sequencing (NGS) Results of Bacteremia or Viremia in Transplant Recipient
Time frame: 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.
Incidence of Bacteremia or Viremia in Transplant Recipient
Time frame: 14 days
1 secondary outcome
Incidence of Acute Rejection in Transplant Recipient
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IVIG in people with Viremia and Bacteremia, run by Shanghai Changzheng Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinghui Yang (021-81885756, yjh@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Next-Generation Sequencing (NGS) Results of Bacteremia or Viremia in Transplant Recipient (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.