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NCT Number: NCT07096453

CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients

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.

Recruiting

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Key information

Conditions

Kidney Transplant; Complications CMV

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Mary Farnsworth

CONTACT

[email protected]

612-624-9695

Vanessa Humphreville, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytogam

Drug

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.

Primary outcomes

  1. Anti-CMV IgG antibody level: Day 0

    Time frame: Day 0, pre-infusion

    Measured with ELISA testing

  2. Anti-CMV IgG antibody level: Day 7

    Time frame: Day 7

    Measured with ELISA testing

  3. Anti-CMV IgG antibody level: Day 14

    Time frame: Day 14

    Measured with ELISA testing

  4. Anti-CMV IgG antibody level: Day 21

    Time frame: Day 21

    Measured with ELISA testing

  5. Anti-CMV IgG antibody level: Day 28

    Time frame: Day 28

    Measured with ELISA testing

  6. Anti-CMV IgG antibody level: Day 56

    Time frame: Day 56 after last dose of CMVIG

    Measured with ELISA testing

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Reed

CONTACT

[email protected]

612-624-9695

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2025
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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