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

Kidney Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05238220
• Other study ID #: Viracor
• Status: Recruiting
• Start date: January 4, 2021
• Est. completion date: June 2023

Study information

• Verified date: February 2022
• Source: Piedmont Healthcare
• Contact: Alexa Ray
• Phone: 404-605-2925
• Email: Alexa.Ray[@]piedmont.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2023
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant; Complications

Intervention

Drug:
• Valganciclovir
continuation of valganciclovir prophylaxis up to 12 months with absence of demonstrated anti-CMV immunity

Locations

Country	Name	City	State
United States	Piedmont Atlanta Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Piedmont Healthcare	ViraCor Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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