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Recruiting Phase 1, Phase 2 NCT07096453

CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients

Trial Parameters

Condition Kidney Transplant; Complications
Sponsor University of Minnesota
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2025-10-02
Completion 2027-08
Interventions
Cytogam

Brief 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

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

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