CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients

Not Applicable

Not yet recruiting

• Conditions: Kidney Transplant; Complications; CMV
• Interventions: Drug: Cytogam

• Registration Number: NCT07096453
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-24
• Study First Posted: 2025-07-31
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-04
• Last Update Posted: 2025-09-08
• Study Start: 2025-10-01
• Primary Completion: 2027-08
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Dose, Day 0	Cytogam	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.
Two Doses, One Week	Cytogam	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.
Two Doses, Four Weeks	Cytogam	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.

Primary Outcome Measures

Name	Time	Method
Anti-CMV IgG antibody level: Day 0	Day 0, pre-infusion	Measured with ELISA testing
Anti-CMV IgG antibody level: Day 7	Day 7	Measured with ELISA testing
Anti-CMV IgG antibody level: Day 14	Day 14	Measured with ELISA testing
Anti-CMV IgG antibody level: Day 21	Day 21	Measured with ELISA testing
Anti-CMV IgG antibody level: Day 28	Day 28	Measured with ELISA testing
Anti-CMV IgG antibody level: Day 56	Day 56 after last dose of CMVIG	Measured with ELISA testing

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States