Actively Recruiting
CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients: a PK Pilot Study
Led by University of Minnesota · Updated on 2025-10-31
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand how Cytogam (CMVIG) interacts with the body and to evaluate if it can help prevent cytomegalovirus (CMV) infection in adults who have received kidney transplants and are transitioning immunosuppression treatments. The study focuses on kidney transplant recipients who are either switching from traditional immunosuppression to belatacept or are already stable on belatacept. It is a Phase 1 and Phase 2 randomized trial sponsored by the University of Minnesota. Participants will receive Cytogam in one of three dosing schedules: a single dose of 150 mg/kg on Day 0, two doses of 150 mg/kg on Day 0 and Day 7, or two doses on Day 0 and Day 28. Belatacept will be given as standard care via intravenous infusion over 30 minutes in an outpatient infusion center. Cytogam infusion starts about 30 minutes after the belatacept infusion is completed. Throughout the study, researchers will monitor anti-CMV IgG antibody levels before infusion on Day 0 and on Days 7, 14, 21, 28, and 56 after the last dose of Cytogam. Participants will be followed closely to assess how the antibody levels change over time. The study involves regular outpatient visits for infusions and blood tests, with the total observation period lasting at least 56 days after the final Cytogam dose.
CONDITIONS
Brief Title
CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult kidney transplant recipients aged 18 to 70 years
- Patients transitioning from conventional CNI-based immunosuppression to belatacept or stable on belatacept immunosuppression at initial Cytogam infusion
- CMV Ig seronegative recipients who received a kidney from a CMV Ig seropositive donor
- EBV IgG positive
You will not qualify if you...
- Pregnant people
- Unable or unwilling to sign consent and complete follow-up visits
- Known IgA immunodeficiency
- Receiving IgG therapy or had IgG therapy within two months before study enrollment
- Non-English speakers requiring translators and translated consent materials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks depending on dosing schedule
Participants receive Cytogam infusions according to their assigned dosing regimen alongside standard Belatacept infusion.
1 to 2 visits depending on dosing regimen within 4 weeks
Duration - Up to 8 weeks after last Cytogam dose
Participants are monitored with antibody level assessments to evaluate the effect of Cytogam over time after treatment.
Approximately 5 visits on Days 7, 14, 21, 28, and 56 after initial dose
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
E
Elise Reed
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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