Kidney Transplant; Complications
Conditions
Brief summary
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.
Detailed description
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.
Interventions
continuation of valganciclovir prophylaxis up to 12 months with absence of demonstrated anti-CMV immunity
Sponsors
Study design
Eligibility
Inclusion criteria
* Able to provide consent * Kidney Transplant Recipients * Classified as CMV high risk at time of transplant (donor CMV IgG positive and recipient CMV IgG negative)
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of Viracor CMV immunity assay | 6 months post-transplant through 12 months prophylaxis | continue valganciclovir prophylaxis for additional time due to absence of demonstrated anti-CMV immunity |
Countries
United States