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.
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
Any pre-transplant CMV serologic combinations besides CMV D+/R-
Multi organ transplants (other than simultaneous liver-kidney transplant (SLK) recipients) or prior history of bone marrow or stem cell transplant
Lung, heart, small bowel, pancreas, or other non-kidney or non-liver transplant recipients
Transplant recipients treated for rejection within three months before the end of valganciclovir prophylaxis
Parallel
Cytomegalovirus Immune Globulin Intravenous (Human) monthly for three months
DrugThe interventional arm will receive Cytomegalovirus Immune Globulin Intravenous (Human) monthly for three months as (150 mg/kg) for 3 consecutive months (Days 0, 28 and 56 +/- 3 days). The non-interventional arm will not receive any intervention.
Number of Participants with Late Clinically Significant CMV Disease
Comparison between treatment groups of number of participants with a blood CMV viral load \>1000 IU/ml at any point during the treatment phase through end of study
Number of Participants with Adverse Events Related to CMV
Congregate data of all Adverse Events (including Serious Adverse Events) will be compared between treatment arms. The number and percent of CMV related AEs will be summarized by: Organ system impacted Relationship to CMV Severity Deaths Those leading to: 1. Initiation of CMV treatment 2. Hospitalization due to CMV
Peak CMV DNA Levels
Comparison of peak CMV DNA levels (DNAemia/viremia) between treatment groups using either the Wilcoxon rank-sum test or Student's t-test, depending on the distribution of the data; DNA tests will be completed every 2 weeks throughout the trial and reported in IU/ml
Change in CMV DNA Levels Across Study Groups
Trend the change and differences in CMV viral loads over time between groups using a mixed-effects model with biweekly CMV DNA test results
Time to First Detectable CMV DNAemia
Time to onset of CMV DNAemia/viremia summarized by treatment group measured by week of onset after day 0 (end of valganciclovir prophylaxis)
Click on the lead sponsor to view all of their trials.
Camille N. Kotton, MD
Lead sponsor
Massachusetts General Hospital
Sponsor institution
University of Texas Southwestern Medical Center
Collaborator
Kamada, Ltd.
Collaborator
