Utilization of the Viracor® Assay for Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| continue valganciclovir prophylaxis continue valganciclovir prophylaxis for up to 12 months total when anti-CMV immunity absent |
Drug: Valganciclovir
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 |
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Piedmont Atlanta Hospital | Atlanta | Georgia | United States | 30309 |
Sponsors and Collaborators
- Piedmont Healthcare
- ViraCor Laboratories
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Viracor