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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-04

Study Completion Date

2022-06-30

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.

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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.

Conditions

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Kidney Transplant; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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continue valganciclovir prophylaxis

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

Valganciclovir

Intervention Type DRUG

continuation of valganciclovir prophylaxis up to 12 months with absence of demonstrated anti-CMV immunity

discontinue valganciclovir prophylaxis

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

No interventions assigned to this group

Interventions

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Valganciclovir

continuation of valganciclovir prophylaxis up to 12 months with absence of demonstrated anti-CMV immunity

Intervention Type DRUG

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)