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OpenTrials
Completed

NCT Number: NCT05238220

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valganciclovir

Drug

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

Primary outcomes

  1. Use of Viracor CMV immunity assay

    Time frame: 6 months post-transplant through 12 months prophylaxis

    continue valganciclovir prophylaxis for additional time due to absence of demonstrated anti-CMV immunity

Sponsors and collaborators

Lead sponsor

Piedmont Healthcare

Other

Collaborators

  • ViraCor Laboratories

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 14, 2022
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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