Back to search results

Letermovir vs Valganciclovir for CMV Prevention in Kidney Transplant

This study is looking at whether letermovir can prevent cytomegalovirus (CMV) infection in people who have received a kidney transplant and are already CMV positive (meaning they've been exposed to CMV before). Researchers will compare patients who received letermovir with a group of past patients who received valganciclovir. Both medications are given for 90 days after the transplant. The main goal is to see if letermovir prevents CMV infection as well as valganciclovir during the first 12 months after a kidney transplant. They will also look at whether letermovir is easier to tolerate. This study plans to enroll 300 participants, but its current status is unclear.

Study design
This interventional study compares letermovir to a historical control group that received valganciclovir. It aims to enroll 300 participants.
What's involved
Participants will receive either letermovir or valganciclovir for 90 days after their kidney transplant. Males must use contraception for 290 days, and females of child-bearing potential must follow contraception guidance for 290 days.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of CMV infection will be measured at 12 months post kidney transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07571135

Letermovir vs Valganciclovir in CMV R+ Kidney Transplant

Not Yet Recruiting
PHASE4Ages 18+InterventionalPrevention
Elisabeth Kincaide
~300 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:LetermovirValganciclovir CMV Prophylaxis

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CMV Infection
Measured over 12 months post kidney transplant

Conditions

CMV Infection
CMV
CMV Viremia
CMV Disease

Explore related trials

Kidney Transplantation

Where it's being run

1 sites across 1 states
Texas1

Who to contact

Elisabeth Kincaide, PharmD
[email protected]
210-743-4086
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

≥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

Exclusion

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
Contraindications per letermovir or acyclovir package insert: patients on pimozide, ergot alkaloids; or pitavastatin and simvastatin when co-administered with cyclosporine

What this trial measures

  • CMV Infection12 months post kidney transplant

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