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CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients

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

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07096453
Enrollment
30
Registered
2025-07-31
Start date
2025-10-02
Completion date
2027-08-31
Last updated
2025-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CMV, Kidney Transplant; Complications

Keywords

Kidney transplant, CMV prevention

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.

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.

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Anti-CMV IgG antibody level: Day 0Day 0, pre-infusionMeasured with ELISA testing
Anti-CMV IgG antibody level: Day 7Day 7Measured with ELISA testing
Anti-CMV IgG antibody level: Day 14Day 14Measured with ELISA testing
Anti-CMV IgG antibody level: Day 21Day 21Measured with ELISA testing
Anti-CMV IgG antibody level: Day 28Day 28Measured with ELISA testing
Anti-CMV IgG antibody level: Day 56Day 56 after last dose of CMVIGMeasured with ELISA testing

Countries

United States

Contacts

Primary ContactElise Reed
surgcto@umn.edu612-624-9695

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026