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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Utilization of the Viracor® Assay in Directing Duration of Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients

Conditions
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Kidney Transplant; Complications

Intervention / Treatment
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* Drug: Valganciclovir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| continue valganciclovir prophylaxis<br>continue valganciclovir prophylaxis for up to 12 months total when anti-CMV immunity absent | Drug: Valganciclovir<br>* continuation of valganciclovir prophylaxis up to 12 months with absence of demonstrated anti-CMV immunity<br>|
| discontinue valganciclovir prophylaxis<br>discontinue valganciclovir prophylaxis when anti-CMV immunity present after routine care prophylaxis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of Viracor CMV immunity assay | continue valganciclovir prophylaxis for additional time due to absence of demonstrated anti-CMV immunity | 6 months post-transplant through 12 months prophylaxis |