Letermovir vs Valganciclovir in CMV R+ Kidney Transplant

NCT07571135 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00000831
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out whether letermovir can help prevent cytomegalovirus (CMV) infection in kidney transplant recipients who are CMV seropositive. To do this, researchers will compare patients who received letermovir with a group of historical patients who received valganciclovir ("mini dose"). Both groups will be on CMV prophylaxis drug for 90 days post-transplant. The main question the study wants to answer is:

• Does letermovir work as well as valganciclovir in preventing CMV infections during the first 12 months after a kidney transplant? The study will also look at other important questions:
• Is letermovir easier for patients to tolerate than valganciclovir?
• How long does it take for a CMV infection to appear in each group?
• Are there differences in "breakthrough" CMV infections between the two medications?
• For patients who develop CMV that becomes resistant to treatment, are the resistance patterns different between the two groups

Conditions

CMV Infection; CMV; CMV Viremia; CMV Disease

Keywords

CMV; Kidney Transplant; Letermovir; Moderate Risk; CMV Prophylaxis; Valganciclovir; Neutropenia

Outcome Measures

Primary Outcomes (1)

• CMV Infection

  Incidence of patients with clinically significant CMV infection at 12 months post kidney transplant in patients who received letermovir versus standard of care valganciclovir.

  12 months post kidney transplant

Study Arms (2)

Letermovir

ACTIVE COMPARATOR

Prospective letermovir prophylaxis

Drug: Letermovir

Valganciclovir

OTHER

Historical valganciclovir prophylaxis

Drug: Valganciclovir CMV Prophylaxis

Interventions

Letermovir DRUG

Letermovir 480 mg PO daily or 240 mg PO daily (if on cyclosporine) for 90 days post kidney transplant

Letermovir

Valganciclovir CMV Prophylaxis DRUG

Valganciclovir 450 mg PO daily for 90 days post kidney transplant (Historical Control)

Valganciclovir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• Kidney transplant recipient with documented CMV IgG seropositive status (R+) within 90 days prior to transplant
• Males agree to use contraception and refraining from donating sperm for 290 days post-treatment initiation
• Females of child-bearing potential agree to follow contraception guidance for 290 days post-treatment initiation

You may not qualify if:

• Multiorgan organ transplant
• Received previous solid organ transplant or HSCT
• Unable to take oral medications
• Uncontrolled infections at the time of enrollment
• Hemodynamically unstable or on mechanical ventilation at the time of enrollment
• Documented HBsAg or detectable HCV RNA 90 days prior to enrollment or HCV+ donor
• Pregnant or breastfeeding or planning to be pregnant, breastfeeding or donating eggs during study period and 90 days post cessation
• Received any anti-CMV drug treatment within 7 days prior to enrollment
• Current user of recreational or illicit drugs or alcohol dependence
• History of CMV disease prior to enrollment
• Previously participated in a letermovir study or any other study with CMV investigational agents
• On dialysis or plasmapheresis at the time of enrollment
• Known or suspected hypersensitivity to active or inactive ingredients from letermovir or acyclovir formulations
• Child-Pugh Class C severe hepatic insufficiency
• Currently participating or has participated in a study with an unapproved compound of device within 28 days or 5 half-lives of this study

Sponsors & Collaborators

• Elisabeth Kincaide: lead

Study Sites (1)

University Hospital

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Cytomegalovirus Infections; Neutropenia

Interventions

letermovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Central Study Contacts

Elisabeth Kincaide, PharmD

CONTACT

210-743-4086; Elisabeth.Kincaide@uhtx.com

Sean Moore, BSN, RN

CONTACT

210-475-2559; Sean.Moore2@uhtx.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Solid Organ Transplant Clinical Pharmacy Specialist

Model Details: Intervention arm with Letermovir compared to historical arm receiving Valganciclovir

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)