Camille N. Kotton, MD
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.
This research study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help people with a high risk for developing late CMV disease post-transplant. Cytomegalovirus (CMV) is a very common virus and in the same family as the viruses that cause herpes, chickenpox, and mononucleosis. Most people become infected with the virus when they come in direct contact with an infected person's bodily fluids. People with a normal immune system who become infected with CMV can have no symptoms or have symptoms similar to the common c…
Inclusion Criteria * 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 Exclusion Criteria * 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 marro…
The 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.
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