NCT06407232 · University of Wisconsin, Madison
Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Letermovir
480 mg taken orally once daily, for 84 days
Primary outcome measures
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)
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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Madison, Wisconsin
Collaborators
Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations