Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients
- Conditions
- Pancreas TransplantCytomegalovirus InfectionsKidney Transplant Infection
- Interventions
- Registration Number
- NCT06407232
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
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.
- Detailed Description
Study Population: Patients over 18 years of age who have undergone kidney or simultaneous kidney/pancreas transplant and are high-risk CMV serostatus (D+/R-) at time of transplant who develop CMV viremia that necessitates treatment per our institutional protocol (enrolled in our CMV stewardship monitoring initiative) and demonstrate proven or presumptive lack of cell-mediated immunity, either by CMI testing or risk factor screening.
Patients will be converted from treatment with ganciclovir derivatives to letermovir (480 mg tablet taken orally once daily) when the viral load via SOC weekly monitoring is \< 500 IU/mL. This differs from SOC which only allows conversion to secondary prophylactic treatment after CMV is no longer detected on PCR for 2 consecutive weeks. Thus, liberalization of conversion threshold will allow for reduced exposure to valganciclovir via reduced duration of therapy allowing relief of the myelosuppressive toxicity and creates an environment conducive to CMI.
The primary objective is to assess the efficacy of letermovir as secondary prophylaxis after treatment of CMV infection.
* Primary hypothesis: letermovir will be associated with reduced duration of (val)ganciclovir treatment and reduced incidence of recurrent viremia.
* Primary endpoint: (val)ganciclovir treatment time will be measured; recurrence will be quantified as number of distinct episodes of any cytomegalovirus replication \> 1000 IU/mL after withdrawal of secondary prophylaxis per previous literature.
The secondary objective is to detect the development of cytomegalovirus-specific cell-mediated immunity as determined by a positive result using the Eurofins-Viracor CMV inSIGHTTM T Cell Immunity Testing per manufacturer specifications.
* Secondary hypothesis: letermovir will be associated with increased development of cytomegalovirus-specific cell-mediated immunity when compared to a literature-based control.
* Secondary endpoint: development of cytomegalovirus-specific cell-mediated immunity as determined by a positive result using the Eurofins-Viracor CMV inSIGHTTM T Cell Immunity Testing per manufacturer specifications at the following timepoints: letermovir initiation (Day 0) and monthly through completion of secondary prophylaxis with a minimum requirement of TCIP at secondary prophylaxis completion.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- undergone kidney or simultaneous kidney/pancreas transplant
- high-risk CMV serostatus (D+/R-) at time of transplant
- develop CMV viremia that necessitates treatment per our institutional protocol (enrolled in the CMV stewardship monitoring initiative)
- demonstrate proven or presumptive lack of CMI, either by CMI testing or risk factor screening
- able to provide informed consent to participate
- contraindication to letermovir or its excipients
- develop ganciclovir-resistant CMV infection
- currently participating in any study involving the administration of a CMV vaccine or another CMV investigational agent
- unable or unwilling, in the opinion of the Investigator, to comply with the protocol
- pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Letermovir for CMV in Transplant Patients Letermovir Enrolled participants will be converted from treatment with ganciclovir derivatives to letermovir
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method Number of Participants with Positive Result for T-Cell Immunity Panel (TCIP) Testing letermovir initiation (Day 0) and monthly through completion of secondary prophylaxis with a minimum requirement of TCIP at secondary prophylaxis completion (Week 12 +/- 28 days) To test the hypothesis that letermovir will be associated with increased development of cytomegalovirus-specific cell-mediated immunity when compared to a literature-based control, development of cytomegalovirus-specific cell-mediated immunity as determined by a positive result using the Eurofins-Viracor CMV inSIGHTTM T-Cell Immunity Testing per manufacturer specifications will be measured.
Trial Locations
- Locations (1)
UW Hospital and Clinics
🇺🇸Madison, Wisconsin, United States