Letermovir for Cytomegalovirus in Kidney Transplants

Overseen By Sean Moore, BSN, RN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Elisabeth Kincaide

Must be taking: CMV prophylaxis

Must not be taking: Anti-CMV drugs, Pimozide

Disqualifiers: Multiorgan transplant, Uncontrolled infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older.

Kidney transplant recipient with documented CMV IgG seropositive status (R+) within 90 days prior to transplant

I agree to use birth control and not donate sperm for 290 days after starting treatment.

Exclusion Criteria

I cannot swallow or take medicines by mouth.

I do not have any uncontrolled infections right now.

Received previous solid organ transplant or HSCT

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either letermovir or valganciclovir for CMV prophylaxis for 90 days post-transplant

12 weeks

Regular visits for monitoring drug administration and side effects

Follow-up

Participants are monitored for CMV infection and drug tolerability for 12 months post-transplant

12 months

Periodic visits for monitoring CMV infection and resistance patterns

What Are the Treatments Tested in This Trial?

Interventions

• Letermovir
• Valganciclovir

How Is the Trial Designed?

Group I: Valganciclovir Experimental Treatment 1 Intervention

Historical valganciclovir prophylaxis

Group II: Letermovir Active Control 1 Intervention

Prospective letermovir prophylaxis

Who Is Running the Clinical Trial?

Elisabeth Kincaide

Lead Sponsor