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Letermovir vs Valganciclovir in CMV R+ Kidney Transplant

NCT07571135 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-08

No results posted yet for this study

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

Interventions

DRUG

Letermovir

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

DRUG

Valganciclovir CMV Prophylaxis

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

Sponsors & Collaborators

  • Elisabeth Kincaide

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-11-30
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07571135 on ClinicalTrials.gov