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.
Looking for future studies?
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
Looking for future studies?
Notify MePiedmont Healthcare
Other
Utilization of the Viracor® Assay in Directing Duration of Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06001320
CMV, Kidney Transplant; Complications
Richmond, Virginia, United States
View Trial DetailsNCT03098706
Body Temperature Changes, Brain Death
Amiens, France
View Trial DetailsNCT06688825
Body Weight, Kidney Transplant; Complications
Richmond, Virginia, United States
View Trial DetailsNCT03071536
Delayed Graft Function, Kidney Function
Bangkok, Thailand
View Trial Details