Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Letermovir.
- Who it may be relevant to
- Registry conditions: Cytomegalovirus Infections, Kidney Transplant Infection, Pancreas Transplant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed description
Study Population: Patients over 18 years of age who have undergone kidney or simultaneous kidney/pancreas transplant and are high-risk CMV serostatus (D+/R-) at time of transplant who develop CMV viremia that necessitates treatment per our institutional protocol (enrolled in our CMV stewardship monitoring initiative) and demonstrate proven or presumptive lack of cell-mediated immunity, either by CMI testing or risk factor screening.
Patients will be converted from treatment with ganciclovir derivatives to letermovir (480 mg tablet taken orally once daily) when the viral load via standard of care (SOC) weekly monitoring is \< 500 IU/mL. This differs from SOC which only allows conversion to secondary prophylactic treatment after CMV is no longer detected on polymerase chain reaction (PCR) for 2 consecutive weeks. Thus, liberalization of conversion threshold will allow for reduced exposure to valganciclovir via reduced duration of therapy allowing relief of the myelosuppressive toxicity and creates an environment conducive to cell-mediated immunity (CMI).
The primary objective is to assess the efficacy of letermovir as secondary prophylaxis after treatment of CMV infection.
The secondary objective is to detect the development of cytomegalovirus-specific cell-mediated immunity as determined by a positive result using the Eurofins-Viracor CMV inSIGHTTM T Cell Immunity Testing per manufacturer specifications.
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)]
- Duration of valganciclovir (VGC) Treatment [Time frame: up to 2 months]
Secondary outcome measures (1)
- Number of Participants with Positive Result for T-Cell Immunity Panel (TCIP) Testing [Time frame: letermovir initiation (Day 0), at secondary prophylaxis completion (Week 12 +/- 28 days)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UW Hospital and Clinics — Madison
Identifiers
NCT: NCT06407232 · 2024-0174 · A561000 · Protocol Version 8/22/25 · 235208