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 — DRUG
    480 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 Patients
    Enrolled 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

Locations (1)

FacilityCityStateZIPSite coordinators
UW Hospital and ClinicsMadisonWisconsin53792
Brad Astor, PhD (SUB_INVESTIGATOR)
Christopher Saddler, MD (SUB_INVESTIGATOR)
Jillian Descourouez, PharmD (SUB_INVESTIGATOR)

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