Last reviewed · How we verify
An Interventional Study of Letermovir for Secondary Prophylaxis After Treatment of Cytomegalovirus Infection in High Risk (D+/R-) Kidney and Kidney/Pancreas Transplant Recipients
This study is designed to assess how effective letermovir is in preventing recurrence of cytomegalovirus (CMV) infection in adult kidney or kidney/pancreas transplant recipients who are UW Health patients. Participants will be in the study for about 6 months.
Details
| Lead sponsor | University of Wisconsin, Madison |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 90 |
| Start date | 2024-08-08 |
| Completion | 2026-09 |
Conditions
- Cytomegalovirus Infections
- Kidney Transplant Infection
- Pancreas Transplant
Interventions
- Letermovir
Primary outcomes
- Number of distinct episodes of any cytomegalovirus replication greater than 1000 IU/mL — up to 90 days after withdrawal of secondary prophylaxis (up to 6 months on study)
To test the hypothesis that letermovir will be associated with reduced incidence of recurrent viremia, recurrence will be measured defined as incidence of any cytomegalovirus replication greater than 1000 IU/mL requiring treatment after withdrawal of secondary prophylaxis. - Duration of valganciclovir (VGC) Treatment — up to 2 months
To test the hypothesis that letermovir will be associated with reduced duration of (val)ganciclovir treatment, the duration of VGC treatment will be measured.
Countries
United States