Piedmont Atlanta Hospital
Atlanta, Georgia, 30309, United States
NCT Number: NCT05238220
The purpose of this study is to evaluate whether the use of the Viracor® CMV immunity assay at 6 months post-transplant in CMV high risk kidney transplant recipients would help identify those patients at higher risk of post-prophylaxis CMV viremia or disease and thereby select those patients in which a longer duration of valganciclovir prophylaxis would be beneficial.
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Notify Me18 year and older
All sexes
Observational
Atlanta, Georgia, 30309, United States
Kidney transplant patients that are cytomegalovirus (CMV) seronegative (IgG negative) at time of transplant and receive a graft from a donor that is CMV seropositive (IgG positive) are at increased risk of developing post-transplant CMV viremia and disease. These patients receive standard CMV prophylaxis with valganciclovir for 6 months post-transplant. However, a considerable proportion of these patients (25 - 42% at our center over the last 5 years) will go on to develop CMV viremia and/or disease after this valganciclovir prophylaxis is discontinued. To date, there is no strong data regarding whether certain patients would benefit from extension of valganciclovir prophylaxis beyond the standard 6-month period.
The purpose of this study is to evaluate whether the use of the Viracor® CMV immunity assay at 6 months post-transplant in CMV high risk kidney transplant recipients would help identify those patients at higher risk of post-prophylaxis CMV viremia or disease and thereby select those patients in which a longer duration of valganciclovir prophylaxis would be beneficial.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
continuation of valganciclovir prophylaxis up to 12 months with absence of demonstrated anti-CMV immunity
Time frame: 6 months post-transplant through 12 months prophylaxis
continue valganciclovir prophylaxis for additional time due to absence of demonstrated anti-CMV immunity
Piedmont Healthcare
Other
Utilization of the Viracor® Assay in Directing Duration of Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients
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