60 Participants Needed

Letermovir for Cytomegalovirus Prophylaxis in Kidney Transplant Recipients

IY
GA
Overseen ByGelila Abebe
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Virginia Commonwealth University
Must be taking: Valganciclovir
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is being done to compare the effectiveness of de novo Letermovir versus valganciclovir in preventing the development of cytomegalovirus viremia or symptomatic disease in African American kidney transplant recipients within the first year after transplantation.There are two arms in the study:Arm 1: Prophylaxis: This group includes freshly transplanted high risk (CMV D+/R-) African American Kidney recipients who will be on prophylactic Letermovir for 6 month.Arm 2: Prophylaxis: This group includes high-risk African American kidney transplant recipients who had already completed the 6 month prophylactic course with the standard of care Valganciclovir.

Will I have to stop taking my current medications?

If you are taking pimozide, ergot alkaloids, or pitavastatin/simvastatin with cyclosporine, you may need to switch to a different medication. The study team will work with your doctor to find a suitable alternative.

Is Letermovir safe for use in humans?

Letermovir is considered to have a good safety profile, with fewer side effects compared to other treatments like valganciclovir, and it does not require dose adjustments for kidney function.12345

How is the drug Letermovir different from other treatments for preventing cytomegalovirus in kidney transplant patients?

Letermovir is unique because it targets the viral terminase complex, which is different from other drugs that target viral polymerase, and it has a better safety profile with less risk of myelotoxicity (bone marrow suppression) and no need for dose adjustment in patients with kidney issues.24678

What data supports the effectiveness of the drug Letermovir for cytomegalovirus prophylaxis in kidney transplant recipients?

Letermovir has been shown to be effective in preventing cytomegalovirus (CMV) infection in patients who have received a hematopoietic stem cell transplant, and it has been used successfully in cases where other treatments were not effective due to resistance or side effects. This suggests it may also be beneficial for kidney transplant recipients at risk of CMV infection.12679

Who Is on the Research Team?

dir VCU School of Medicine

Gaurav Gupta, MD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for African American adults who've received a kidney transplant and are at high risk for Cytomegalovirus (CMV) because they got the virus from the donor. It's not open to those who have already been treated with valganciclovir for CMV or have certain transplant-related complications.

Inclusion Criteria

Ability to provide informed consent before any trial related activities
I have received a kidney transplant.
I am at high risk for CMV due to donor/recipient status.
See 2 more

Exclusion Criteria

Patients with hypersensitivity to Letermovir or any of its components
I am not taking pimozide, ergot alkaloids, or certain cholesterol medicines with cyclosporine.
Positive cytotoxic cross match at the time of transplant
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive prophylactic Letermovir or are assessed retrospectively for Valganciclovir use for CMV prophylaxis

6 months
Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety, effectiveness, and secondary outcomes such as leukopenia and allograft rejection

up to 1 year
Periodic visits for assessment and monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • Letermovir
Trial Overview The study is testing if Letermovir, taken once daily, is effective in preventing CMV compared to Valganciclovir, following guidelines by the AST ID COP. Participants will be monitored and treated accordingly if they develop CMV viremia.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Letermovir group (study group)Experimental Treatment1 Intervention
Group II: Historical Control study groupExperimental Treatment1 Intervention

Letermovir is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Prevymis for:
🇪🇺
Approved in European Union as Prevymis for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials
732
Recruited
22,900,000+

Merck Sharp & Dohme LLC

Industry Sponsor

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

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

Robert M. Davis profile image

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

Published Research Related to This Trial

Letermovir, an antiviral agent typically used for preventing CMV infection in stem cell transplant recipients, was successfully used off-label to treat a patient with resistant CMV disease after renal transplant.
This case report is significant as it demonstrates the effectiveness of combining letermovir with hyperimmune CMV immunoglobulin for treating high viral load CMV infections, providing a potential alternative when standard treatments are inadequate.
Successful Treatment of UL97 Mutation Ganciclovir-Resistant Cytomegalovirus Viremia in a Renal Transplant Recipient With Letermovir and Adjunct Hyperimmune Cytomegalovirus Immunoglobulin: A Case Report.Pearston, AP., Ingemi, AI., Ripley, K., et al.[2021]
Letermovir (Prevymis™) is an effective prophylactic treatment for preventing cytomegalovirus (CMV) infection and disease in adult patients who are CMV-seropositive and have received an allogeneic hematopoietic stem cell transplant, with approvals in Canada and the USA.
The drug works by inhibiting the CMV DNA terminase complex and has received positive regulatory feedback in Europe, indicating its potential for broader international use.
Letermovir: First Global Approval.Kim, ES.[2019]
Letermovir, an anti-CMV drug, was successfully used to treat ganciclovir-resistant CMV colitis in a heart transplant recipient, demonstrating its potential as a curative option.
In a second case, while letermovir was used as pre-emptive therapy for CMV reactivation, it did not prevent CMV esophagitis, indicating that while effective for secondary prophylaxis, it may not always prevent all forms of CMV-related complications.
Letermovir use to treat complex cytomegalovirus reactivations in two heart transplant recipients.Boignard, A., Augier, C., Kheng, M., et al.[2022]

Citations

Successful Treatment of UL97 Mutation Ganciclovir-Resistant Cytomegalovirus Viremia in a Renal Transplant Recipient With Letermovir and Adjunct Hyperimmune Cytomegalovirus Immunoglobulin: A Case Report. [2021]
Letermovir: First Global Approval. [2019]
Letermovir use to treat complex cytomegalovirus reactivations in two heart transplant recipients. [2022]
Pharmacokinetics and safety of letermovir, a novel anti-human cytomegalovirus drug, in patients with renal impairment. [2021]
Letermovir treatment of cytomegalovirus infection or disease in solid organ and hematopoietic cell transplant recipients. [2021]
Letermovir Prophylaxis for CMV Reactivation in Allogeneic Stem Cell Recipients: A Retrospective Single Center Analysis. [2022]
A new direction for cytomegalovirus prophylaxis among transplant recipients: Benefits and nonviral outcomes of letermovir use as primary CMV prophylaxis. [2023]
Letermovir successfully used for secondary prophylaxis in a heart transplant recipient with ganciclovir-resistant cytomegalovirus syndrome (UL97 mutation). [2019]
Use of Letermovir for Primary and Secondary Cytomegalovirus Prophylaxis in Abdominal Organ Transplantation: A Single Center Experience. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security