Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients

Launched by UNIVERSITY OF WISCONSIN, MADISON · May 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called letermovir (also known as Prevymis) to see how well it works in preventing cytomegalovirus (CMV) infections in adults who have received kidney or kidney/pancreas transplants. CMV can be a serious concern for transplant recipients, especially those at high risk. If you are between the ages of 18 and 74 and have recently undergone one of these transplants, you may be eligible to participate in the study if you have a specific type of CMV risk and require treatment for the virus.

Participants in the trial will be monitored for about six months. During this time, they will receive letermovir and be closely observed for any changes in their health related to CMV. It's important to note that individuals who are pregnant, breastfeeding, or have certain health conditions may not be able to join the study. This research aims to provide valuable information on how to better prevent CMV infections in transplant patients, ultimately helping improve their health outcomes.

Gender

ALL

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