Using letermovir to prevent CMV infection in kidney and pancreas transplant patients
An Interventional Study of Letermovir for Secondary Prophylaxis After Treatment of Cytomegalovirus Infection in High Risk (D+/R-) Kidney and Kidney/Pancreas Transplant Recipients
This study is testing if letermovir can help prevent CMV infections in adult kidney and pancreas transplant patients who are at high risk, while reducing their need for another medication called ganciclovir.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06407232 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of letermovir in preventing the recurrence of cytomegalovirus (CMV) infection in adult kidney and simultaneous kidney/pancreas transplant recipients who are at high risk for CMV. Participants will switch from ganciclovir derivatives to letermovir once their viral load is below a specified threshold, allowing for reduced exposure to ganciclovir and its associated side effects. The primary goal is to determine if letermovir can decrease the duration of ganciclovir treatment and the incidence of recurrent CMV viremia. The study will last approximately six months and involves close monitoring of viral loads.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have undergone kidney or simultaneous kidney/pancreas transplants and have a high-risk CMV serostatus.
Not a fit: Patients who have contraindications to letermovir, ganciclovir-resistant CMV infections, or are currently involved in other CMV-related studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of CMV infections in transplant recipients, reducing the need for prolonged ganciclovir therapy and its side effects.
How similar studies have performed: Other studies have shown promise in using letermovir for CMV prevention, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madison, Wisconsin
- UW Hospital and Clinics — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Sandesh Parajuli, MBBS — University of Wisconsin, Madison
- Study coordinator: Sandesh Parajuli, MBBS
- Email: sparajuli@medicine.wisc.edu
- Phone: (608) 262-2122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.