Using letermovir to prevent CMV infection in kidney and pancreas transplant patients
Official title: An Interventional Study of Letermovir for Secondary Prophylaxis After Treatment of Cytomegalovirus Infection in High Risk (D+/R-) Kidney and Kidney/Pancreas Transplant Recipients
Run by University of Wisconsin, Madison · NCT06407232 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Status | Recruiting |
| Started | August 8, 2024 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | June 11, 2026 |
| Trial ID | NCT06407232 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 who have undergone kidney or simultaneous kidney/pancreas transplants and have a high-risk CMV serostatus.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise in using letermovir for CMV prevention, indicating that this approach is supported by prior research.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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CMV-specific T cells after CMV reactivation in adults after HSCT
This study tests CMV-specific immune recovery in adults who have their first CMV reactivation after an allogeneic HSCT to see how CMV-specific T cells change over time.
-
Biomarkers linked to congenital CMV using newborn blood spots
Researchers will test protein and RNA markers in dried blood spots from newborns to see if they can identify congenital CMV sequelae early.
-
T-cell–guided letermovir stopping after allogeneic stem cell transplant
This tests whether using a CMV-specific T-cell blood test to decide when adult CMV-positive patients can stop letermovir after allogeneic stem cell transplant keeps them protected while avoiding unnecessary drug exposure.
-
Long-term health of children born to mothers who had a solid organ transplant
This project will look for long-term heart, kidney, and immune system problems in people aged 16 and older who were born to mothers who had a kidney, liver, pancreas, heart, or lung transplant.
-
Family-donor viral CTLs plus standard care vs standard care alone for refractory ADV or CMV infection after stem cell transplant
This study tests whether using family-donor virus-specific CTLs in addition to usual treatment helps children, teens, and young adults with hard-to-treat CMV or adenovirus infections after a stem cell transplant.
-
CMV-specific immunoglobulin to prevent CMV problems in children getting allogeneic stem cell transplants
Doctors will try giving CMV-specific immunoglobulin to children having allogeneic stem cell transplants to prevent CMV reactivation and related transplant complications.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.