Exploratory Use of CMV Immunoglobulin in High Risk (D+R-) Transplant Recipients at the End of Antiviral Prophylaxis to Decrease the Risk of Late CMV Infection
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help transplant recipients with a high risk for developing late CMV disease after a liver and/or kidney transplant.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• High risk pretransplant CMV donor seropositive/recipient seronegative (D+R-) kidney, liver, or simultaneous liver-kidney (SLK) transplant recipients
• Able to do routine blood testing (normal care for transplant recipients)
• Written informed consent obtained from the subject before any trial-related procedures
• Be ≥18 years and ≤75 years of age at time of consent
Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Texas
University of Texas Southwestern
RECRUITING
Dallas
Contact Information
Primary
Amelia Stocking, BS
astocking@mgh.harvard.edu
617-643-4087
Backup
Camille Kotton, MD
ckotton@mgh.harvard.edu
6177240084
Time Frame
Start Date: 2025-11-27
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 80
Treatments
Experimental: Arm A: CytoGam®
Participants assigned to receive CytoGam® will receive an infusion once a month for three months at their study site. The infusion will be completed over an average of about 4 hours; these three visits will last about 5 hours. During these study staff will review concomitant medications and adverse events. Participants will be asked to have blood taken at infusion visits and 2 weeks after an infusion visit to check the level of CMV DNA in their blood.
No_intervention: Arm B: Standard of Care
Participants assigned to Arm B, will be asked to complete a telephone call visit once a month. During these visits, a member of study staff will review concomitant medications and adverse events. Participants will be asked to have their blood taken every two weeks to check the level of CMV DNA.
Related Therapeutic Areas
Sponsors
Collaborators: Kamada, Ltd., University of Texas Southwestern Medical Center
Leads: Camille N. Kotton, MD