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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-08

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cytomegalovirus Infections Kidney Transplant Infection Pancreas Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Letermovir for CMV in Transplant Patients

Enrolled participants will be converted from treatment with ganciclovir derivatives to letermovir

Group Type EXPERIMENTAL

Letermovir

Intervention Type DRUG

480 mg taken orally once daily, for 84 days

Interventions

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Letermovir

480 mg taken orally once daily, for 84 days

Intervention Type DRUG

Other Intervention Names

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Prevymis

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No