NCT06407232 Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients
| NCT ID | NCT06407232 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Wisconsin, Madison |
| Condition | Cytomegalovirus Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-08-08 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 90 participants in total. It began in 2024-08-08 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Sandesh Parajuli, MBBS
PRINCIPAL INVESTIGATOR
University of Wisconsin, Madison
Frequently Asked Questions
Who can join the NCT06407232 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cytomegalovirus Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06407232 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 90 participants.
Is NCT06407232 currently recruiting?
Yes, NCT06407232 is actively recruiting participants. Contact the research team at sparajuli@medicine.wisc.edu for enrollment information.
Where is the NCT06407232 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT06407232 clinical trial?
NCT06407232 is sponsored by University of Wisconsin, Madison. The principal investigator is Sandesh Parajuli, MBBS at University of Wisconsin, Madison. The trial plans to enroll 90 participants.