CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients

University of Minnesota (UMN)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Kidney Transplant; Complications; CMV

Treatments: Drug: Cytogam

Study type: Interventional

Funder types: Other

Identifiers

NCT07096453

SURG-2024-32817

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Single Dose, Day 0

Experimental group

Description:

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.

Treatment:

Drug: Cytogam

Two Doses, One Week

Experimental group

Description:

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.

Treatment:

Drug: Cytogam

Two Doses, Four Weeks

Experimental group

Description:

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.

Treatment:

Drug: Cytogam