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Virus Therapy

Letermovir for Cytomegalovirus Prophylaxis in Kidney Transplant Recipients

Phase < 1

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post-transplant

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of cytomegalovirus viremia (defined as CMV PCR > 137 units/ml) or symptomatic disease in AA kidney transplant recipients

Secondary outcome measures

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Letermovir group (study group)Experimental Treatment1 Intervention

Letermovir 480 mg once daily

Group II: Historically matched AA kidney transplant recipients who received valganciclovirExperimental Treatment1 Intervention

Compare outcomes to a historical group of 50 AA kidney transplant recipients who have received valganciclovir prophylaxis

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,046 Total Patients Enrolled

Virginia Commonwealth UniversityLead Sponsor

699 Previous Clinical Trials

22,884,945 Total Patients Enrolled

Gaurav Gupta, MDPrincipal InvestigatorVirginia Commonwealth University

5 Previous Clinical Trials

137 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total participatory count for this experiment?

"Affirmative. According to clinicaltrials.gov, an updated version of this research was posted on October 21st 2023; the original post taking place on September 25th 2023. The trial is now recruiting 100 participants at 1 site."

Answered by AI

Are participants currently being recruited for this research endeavor?

"Affirmative. The clinicaltrials.gov listing indicates that this trial is currently enrolling participants; the original posting was made on September 25th 2023 and recently revised on October 21st 2023. Its target recruitment of 100 patients will take place at a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Trans Recip

2023. "De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Trans Recip". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06001320.

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