CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients: a PK Pilot Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Elise Reed
surgcto@umn.edu
612-624-9695
Time Frame
Start Date: 2025-10-02
Estimated Completion Date: 2027-08
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Minnesota