Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients
Part of paid clinical trials in Madison, Wisconsin.
- Sponsor
- University of Wisconsin, Madison
- Study ID
- NCT06407232
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Cytomegalovirus Infections
- Kidney Transplant Infection
- Pancreas Transplant
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Letermovir — DRUG480 mg taken orally once daily, for 84 days
Study Details
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.
Key Dates
- Start date
- Aug 8, 2024
- Status verified
- Jun 2026
- Primary completion
- Aug 31, 2027
- Completion
- Aug 31, 2027
Study Design
- Enrollment
- 90 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Letermovir for CMV in Transplant PatientsEnrolled participants will be converted from treatment with ganciclovir derivatives to letermovir
Primary Outcome Measure
Number of distinct episodes of any cytomegalovirus replication greater than 1000 IU/mL [ Time Frame: up to 90 days after withdrawal of secondary prophylaxis (up to 6 months on study) ]
Central Contacts
- Sandesh Parajuli, MBBS(608) 262-2122
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UW Hospital and Clinics | Madison | Wisconsin | 53792 | Brad Astor, PhD (SUB_INVESTIGATOR) Christopher Saddler, MD (SUB_INVESTIGATOR) Jillian Descourouez, PharmD (SUB_INVESTIGATOR) |
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