CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients
NCT ID: NCT07096453
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2025-10-02
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Single Dose, Day 0
CMVIG 150 mg/kg x 1 at Day 0. Belatacept will be administered per standard of care (IV infusion over 30 minutes in an outpatient specialty infusion center). Cytogam will be administered according to the assigned dosing regimen starting 30 minutes after completion of Belatacept infusion.
Cytogam
Cytogam is used for the prevention of cytomegalovirus (CMV) disease in kidney, lung, liver, pancreas, heart and bone marrow transplantation. We do not yet have data about how much cytogam reduces CMV in blood, or how quickly it reduces CMV in blood.
Two Doses, One Week
CMVIG 150 mg/kg x 2. Dose #1: Day 0, Dose #2: Day 7. Belatacept will be administered per standard of care (IV infusion over 30 minutes in an outpatient specialty infusion center). Cytogam will be administered according to the assigned dosing regimen starting 30 minutes after completion of Belatacept infusion.
Cytogam
Cytogam is used for the prevention of cytomegalovirus (CMV) disease in kidney, lung, liver, pancreas, heart and bone marrow transplantation. We do not yet have data about how much cytogam reduces CMV in blood, or how quickly it reduces CMV in blood.
Two Doses, Four Weeks
CMVIG 150 mg/kg x 2. Dose #1: Day 0, Dose #2: Day 28. Belatacept will be administered per standard of care (IV infusion over 30 minutes in an outpatient specialty infusion center). Cytogam will be administered according to the assigned dosing regimen starting 30 minutes after completion of Belatacept infusion.
Cytogam
Cytogam is used for the prevention of cytomegalovirus (CMV) disease in kidney, lung, liver, pancreas, heart and bone marrow transplantation. We do not yet have data about how much cytogam reduces CMV in blood, or how quickly it reduces CMV in blood.
Interventions
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Cytogam
Cytogam is used for the prevention of cytomegalovirus (CMV) disease in kidney, lung, liver, pancreas, heart and bone marrow transplantation. We do not yet have data about how much cytogam reduces CMV in blood, or how quickly it reduces CMV in blood.
Eligibility Criteria
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Inclusion Criteria
* Patients transitioning from conventional CNI-based immunosuppression to co-stimulatory blockade (belatacept) immunosuppression OR patients who are stable on belatacept immunosuppression at the time of initial CYTOGAM infusion
* CMV Ig Seronegative Recipient who received a CMV Ig seropositive Donor
* EBV IgG Positive
Exclusion Criteria
* Subjects unwilling to sign consent and complete follow up visits
* Subjects with IgA immunodeficiency
* Subjects who are receiving IgG therapy or who have received IgG therapy within two months of study enrollment
* Patients who do not speak English and would need a translator and translated consent materials in order to obtain informed consent
18 Years
70 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Vanessa Humphreville, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SURG-2024-32817
Identifier Type: -
Identifier Source: org_study_id
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