The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
Valcyte per package insert guidelines for 200 days post transplant
100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant
valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant
Medical University of South Carolina
Charleston, South Carolina, United States
Number of Patients With Late CMV Disease
Number of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant
Time frame: after 200 days post-transplant until 2 years post-transplant
Number of Patients With Early CMV Infection
Time frame: 100 days
Number of Patients With Cell Mediated Immunity
Positive CMV quantiferon at last follow-up
Time frame: 2 years
Renal Function
Renal function will be assessed by an estimated creatinine clearance utilizing the abbreviated Modification of Diet in Renal Disease (MDRD) equation at 6, 12, and 24 months after transplant
Time frame: 6, 12, and 24 months after transplant
Number of Participants With Acute Cellular and/or Antibody Mediated Rejection
Time frame: 2 years
Number of Participants With Opportunistic Infections
Time frame: 2 years
Number of Participants With Asymptomatic CMV Viremia
Time frame: 2 years
Number of Participants With CMV Seroconversions
Time frame: 2 years
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