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

Completed

• Conditions: Kidney Transplant; Complications
• Interventions: Drug: Valganciclovir

• Registration Number: NCT05238220
• Lead Sponsor: Piedmont Healthcare

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.

Study Timeline

• Study Start: 2021-01-04
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-14
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
continue valganciclovir prophylaxis	Valganciclovir	continue valganciclovir prophylaxis for up to 12 months total when anti-CMV immunity absent

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Piedmont Atlanta Hospital; 🇺🇸 Atlanta, Georgia, United States