Recruiting
Phase 1
Phase 2

CMVIG

Sponsor:

University of Minnesota

Code:

NCT07096453

Conditions

Kidney Transplant; Complications

CMV

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Cytogam

Study Details

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.

Conditions

Kidney Transplant; Complications

CMV

Study ID

NCT07096453

Start date

Oct 2, 2025

Status verified date

Oct, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Single Dose, Day 0

CMVIG 150 mg/kg x 1 at Day 0. Belatacept will be administered per standard of care (IV infusion over 30 minutes in an outpatient specialty infusion center). Cytogam will be administered according to the assigned dosing regimen starting 30 minutes after completion of Belatacept infusion.

experimental: Two Doses, One Week

CMVIG 150 mg/kg x 2. Dose #1: Day 0, Dose #2: Day 7. Belatacept will be administered per standard of care (IV infusion over 30 minutes in an outpatient specialty infusion center). Cytogam will be administered according to the assigned dosing regimen starting 30 minutes after completion of Belatacept infusion.

experimental: Two Doses, Four Weeks

CMVIG 150 mg/kg x 2. Dose #1: Day 0, Dose #2: Day 28. Belatacept will be administered per standard of care (IV infusion over 30 minutes in an outpatient specialty infusion center). Cytogam will be administered according to the assigned dosing regimen starting 30 minutes after completion of Belatacept infusion.

Interventions

Cytogam

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 outcome measure

  • Anti-CMV IgG antibody level: Day 0 [ Time Frame: Day 0, pre-infusion ]
  • Anti-CMV IgG antibody level: Day 7 [ Time Frame: Day 7 ]
  • Anti-CMV IgG antibody level: Day 14 [ Time Frame: Day 14 ]
  • Anti-CMV IgG antibody level: Day 21 [ Time Frame: Day 21 ]
  • Anti-CMV IgG antibody level: Day 28 [ Time Frame: Day 28 ]
  • Anti-CMV IgG antibody level: Day 56 [ Time Frame: Day 56 after last dose of CMVIG ]

Central Contacts and Locations

Central contacts

Elise Reed

612-624-9695surgcto@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Mary Farnsworth

612-624-9695ewigx005@umn.edu

Principal Investigator:

Vanessa Humphreville, MD

More Information

Sponsor

University of Minnesota

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

  • Kidney transplant
  • CMV prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Minnesota on 2025-10-31.