Letermovir for Kidney and Liver Transplant Patients

(MISP CMV Trial)

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Overseen ByMargaret R Jorgenson, PharmD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the medication letermovir can prevent cytomegalovirus (CMV) in individuals who have undergone a kidney or liver transplant. CMV can lead to serious health issues, making its prevention crucial for transplant patients. Participants will take the medication for 84 days to assess its effectiveness. This trial suits those who have had a kidney or liver transplant and have previously been exposed to CMV. As a Phase 4 trial, it involves an FDA-approved treatment, furthering the understanding of its benefits for more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for this treatment?

Research has shown that letermovir is a safe option for preventing cytomegalovirus (CMV) in transplant patients. Studies have found it easy for patients to tolerate, with few side effects. One study discovered that it led to low rates of CMV infections in patients. Another study highlighted that letermovir is gentler on patients compared to some other antiviral drugs, reducing the likelihood of unwanted side effects. Overall, letermovir maintains a strong safety record for transplant patients, including those who have undergone kidney or liver transplants.12345

Why are researchers enthusiastic about this study treatment?

Letermovir is unique because it targets cytomegalovirus (CMV) infections specifically, which is a common concern for kidney and liver transplant patients. Unlike standard antiviral treatments like ganciclovir or valganciclovir, which can have significant side effects such as bone marrow suppression, letermovir offers a different mechanism of action by inhibiting the CMV terminase complex. This makes it potentially safer and more tolerable for patients who have undergone transplants. Researchers are excited because it could provide an effective and safer alternative for preventing CMV infections in these vulnerable patients.

What evidence suggests that letermovir might be an effective treatment for preventing CMV in kidney and liver transplant patients?

Studies have shown that letermovir effectively prevents complications from cytomegalovirus (CMV) in transplant patients. Specifically, 92.1% of kidney transplant recipients successfully completed six months of antiviral protection with letermovir. Research indicates that it lowers the risk of CMV-related problems and reduces death rates. Letermovir is already approved for use in kidney transplant patients at high risk for CMV. This trial will also evaluate its safety and effectiveness in preventing CMV in liver transplant patients.23678

Who Is on the Research Team?

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David Al-Adra, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for people who have received a kidney or liver transplant and have already been exposed to the CMV virus. Participants should be healthy enough after their transplant to join the study.

Inclusion Criteria

I am an adult at moderate risk for CMV after my transplant.
I am an adult who has received a kidney or liver transplant.

Exclusion Criteria

Current participation in another CMV related study
I have a known allergy or reaction to letermovir or its ingredients.
I am not able or willing to follow the study requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive letermovir for primary prophylaxis of CMV infection

12 weeks
Regular visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Letermovir

Trial Overview

The study tests if taking letermovir for about three months can prevent CMV infection in kidney or liver transplant patients who were previously exposed to this virus.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Receive letermovirExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
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Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

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Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

Real-World Outcomes Associated With Letermovir Use ... - PMC

Letermovir for CMV PP was effective in reducing the risk of CMV-related complications overall and mortality beyond day 200 among adult allo-HCT recipients.

Letermovir vs Valganciclovir for Prophylaxis of ...

This randomized clinical trial compares the efficacy and safety of letermovir vs valganciclovir prophylaxis for cytomegalovirus (CMV) ...

88. Letermovir as CMV Prophylaxis in Liver Transplant ...

Letermovir has emerged as a safe and effective antiviral agent for CMV prophylaxis in allogeneic HCT recipients and high-risk kidney ...

Letermovir Prophylaxis for Cytomegalovirus in ...

All-cause mortality at week 48 after transplantation was 20.9% among letermovir recipients and 25.5% among placebo recipients.

Impact of kidney function on 200 days of antiviral ...

These data support that letermovir is an effective once daily option for CMV prophylaxis with the advantage that it does not require a change to dose frequency

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41664561/

Real-World Off-Label Use of Letermovir Prophylaxis for ...

Conclusion: In this cohort of non-kidney solid organ recipients, letermovir was well tolerated with low rates of clinically significant breakthrough infections.

Medline ® Abstract for Reference 78 of 'Infectious ...

OBJECTIVE To compare the efficacy and safety of letermovir with valganciclovir for prevention of CMV disease in CMV-seronegative kidney transplant recipients ...

Letermovir Approved for Cytomegalovirus Prophylaxis in ...

letermovir is an equally effective and better tolerated antiviral option when used as universal prophylaxis in high-risk kidney transplant ...