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CMVIG for Kidney Transplant Patients on Belatacept

This study is looking at how a medicine called Cytogam works in the body to prevent cytomegalovirus (CMV) infection in kidney transplant patients. CMV is a common virus that can cause problems after a transplant. We want to see if Cytogam can help prevent these infections. You might be able to join if you are an adult (18-70 years old) kidney transplant recipient who is either switching to or already taking belatacept for your immune system. You also need to have received a kidney from a donor who had CMV, while you did not. The study will measure your anti-CMV IgG antibody levels on Day 0, Day 7, and Day 14 to see if Cytogam is working. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 30 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your anti-CMV IgG antibody levels will be measured on Day 0, Day 7, and Day 14.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07096453

CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients

Recruiting
PHASE1Ages 18–70InterventionalPrevention
University of Minnesota
~30 participants
Updated 2025-10-31 on ClinicalTrials.gov
What's tested:Cytogam

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Anti-CMV IgG antibody level: Day 0
Measured over Day 0, pre-infusion
+5 more outcomes measured

Conditions

Kidney Transplant; Complications
CMV

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Cytomegaloviral InfectionKidney TransplantationX-linked Lymphoproliferative Syndrome 1

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Vanessa Humphreville, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Elise Reed
[email protected]
612-624-9695
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Anti-CMV IgG antibody level: Day 0Day 0, pre-infusion

    Measured with ELISA testing

  • Anti-CMV IgG antibody level: Day 7Day 7

    Measured with ELISA testing

  • Anti-CMV IgG antibody level: Day 14Day 14

    Measured with ELISA testing

  • Anti-CMV IgG antibody level: Day 21Day 21

    Measured with ELISA testing

  • Anti-CMV IgG antibody level: Day 28Day 28

    Measured with ELISA testing

  • Anti-CMV IgG antibody level: Day 56Day 56 after last dose of CMVIG

    Measured with ELISA testing