NCT07096453PHASE1, PHASE2Recruiting
CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients
University of Minnesota
Start Date
10/2/2025
Completion Date
8/1/2027
Summary
The purpose of this study is to study how CMVIG interacts with the body and to see if it might work to prevent kidney transplant patients from becoming infected with CMV.
Eligibility Criteria
Age Range: 18 years to 70 years
Inclusion Criteria:
* Adult (18-70 year old) kidney transplant recipients
* 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:
* Pregnant people
* 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
Interventions
DRUG
Cytogam
Conditions
Kidney Transplant; ComplicationsCMV
Locations
University of Minnesota
Minneapolis, Minnesota 55455
United States