Utilization of the Viracor® Assay for Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients

Piedmont Healthcare

Status: Completed

Conditions: Kidney Transplant; Complications

Treatments: Drug: Valganciclovir

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05238220

Viracor

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

37 participants in 2 patient groups

continue valganciclovir prophylaxis

Description:

continue valganciclovir prophylaxis for up to 12 months total when anti-CMV immunity absent

Treatment:

Drug: Valganciclovir

discontinue valganciclovir prophylaxis

Description:

discontinue valganciclovir prophylaxis when anti-CMV immunity present after routine care prophylaxis