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Virus Therapy

Letermovir for Cytomegalovirus Prophylaxis in Kidney Transplant Recipients

Phase 4
Recruiting
Led By Gaurav Gupta, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post-transplant
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

Summary

This trial tests CMV treatments, recommended by AST ID COP, to see if they work.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of Letermovir include headache, nausea, vomiting, and diarrhea. Valganciclovir can cause similar digestive issues as well as potential blood cell count changes leading to anemia or lower immunity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of cytomegalovirus viremia (defined as CMV PCR > 137 units/ml) or symptomatic disease in AA kidney transplant recipients
Secondary study objectives
Correlation between CYP3A5*1 and its impact on tacrolimus metabolism and incidence of kidney allograft rejection up to 1 year post-transplant
Impact of Pharmacologic CMV Prophylaxis on Mycophenolate dosage up to 6 months post-transplant
Impact of Pharmacological Prophylaxis on CMV T-Cell immunity up to 1 year post-transplant
+4 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Letermovir group (study group)Experimental Treatment1 Intervention
Letermovir 480 mg once daily
Group II: Historical Control study groupExperimental Treatment1 Intervention
Historically matched AA kidney transplant recipients who received the standard of care 450mg once a day valganciclovir prophylaxis

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,019 Previous Clinical Trials
5,186,447 Total Patients Enrolled
Virginia Commonwealth UniversityLead Sponsor
716 Previous Clinical Trials
22,888,438 Total Patients Enrolled
Gaurav Gupta, MDPrincipal InvestigatorVirginia Commonwealth University
6 Previous Clinical Trials
142 Total Patients Enrolled
~23 spots leftby Sep 2025
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