Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT05799716
Status:
UNKNOWN
Last Update Posted:
2023-04-05
First Post:
2023-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014766', 'term': 'Viremia'}, {'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-03', 'studyFirstSubmitDate': '2023-03-13', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Next-Generation Sequencing (NGS) Results of Bacteremia or Viremia in Transplant Recipient', 'timeFrame': '14 days', 'description': 'NGS is a technology for determining the sequence of DNA or RNA to study genetic variation associated with diseases like bacteremia and viremia.'}, {'measure': 'Incidence of Bacteremia or Viremia in Transplant Recipient', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of Acute Rejection in Transplant Recipient', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IVIG Infection'], 'conditions': ['Viremia', 'Bacteremia', 'Acute Rejection of Renal Transplant']}, 'descriptionModule': {'briefSummary': '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:\n\n1. How effective IVIG is in preventing donor-derived infections\n2. Does IVIG has potential immunomodulatory effect on transplanted organs', 'detailedDescription': '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.\n\nIntravenous 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any person approved as a transplant donor with recipient who has never undergone a previous transplantation\n* Transplant donor must be 6 years old or older\n* They must have provided signed informed consent\n* The donors must be willing to contribute samples of blood\n\nExclusion Criteria:\n\n* Any potential transplant donor who is receiving or have received anti-herpes medication in the past week\n* Any potential transplant donor to a recipient who has received a previous solid organ transplant\n* Any potential transplant donor who is immunosuppressed due to medical disease and/or immunosuppressive or immunomodulating medications\n* Any potential transplant donor who is on corticosteroids'}, 'identificationModule': {'nctId': 'NCT05799716', 'briefTitle': 'Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Changzheng Hospital'}, 'officialTitle': 'Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections', 'orgStudyIdInfo': {'id': 'CT20230313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IVIG', 'interventionNames': ['Drug: IVIG']}, {'type': 'NO_INTERVENTION', 'label': 'Sham'}], 'interventions': [{'name': 'IVIG', 'type': 'DRUG', 'description': '0.5g/Kg', 'armGroupLabels': ['IVIG']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jinghui Yang', 'role': 'CONTACT', 'email': 'yjh@smmu.edu.cn', 'phone': '021-81885756'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}