CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients

NCT07096453 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SURG-2024-32817
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Kidney transplant; CMV prevention

Outcome Measures

Primary Outcomes (6)

• Anti-CMV IgG antibody level: Day 0

  Measured with ELISA testing

  Day 0, pre-infusion

• Anti-CMV IgG antibody level: Day 7

  Measured with ELISA testing

  Day 7

• Anti-CMV IgG antibody level: Day 14

  Measured with ELISA testing

  Day 14

• Anti-CMV IgG antibody level: Day 21

  Measured with ELISA testing

  Day 21

• Anti-CMV IgG antibody level: Day 28

  Measured with ELISA testing

  Day 28

• Anti-CMV IgG antibody level: Day 56

  Measured with ELISA testing

  Day 56 after last dose of CMVIG

Study Arms (3)

Single Dose, Day 0

EXPERIMENTAL

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.

Drug: Cytogam

Two Doses, One Week

EXPERIMENTAL

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.

Drug: Cytogam

Two Doses, Four Weeks

EXPERIMENTAL

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.

Drug: Cytogam

Interventions

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.

Single Dose, Day 0; Two Doses, Four Weeks; Two Doses, One Week

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Interventions

cytomegalovirus-specific hyperimmune globulin

Study Officials

• Vanessa Humphreville, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise Reed

CONTACT

612-624-9695; surgcto@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)