RecruitingPhase 1Phase 2NCT07096453

CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients

CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients: a PK Pilot Study


Sponsor

University of Minnesota

Enrollment

30 participants

Start Date

Oct 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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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Interventions

DRUGCytogam

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.


Locations(1)

University of Minnesota

Minneapolis, Minnesota, United States

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NCT07096453


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