De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients

NCT06001320 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: HM20027540
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplant; Complications; CMV

Outcome Measures

Primary Outcomes (1)

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

  The incidence of cytomegalovirus viremia (defined as CMV PCR \> 137 units/ml) or symptomatic disease in AA kidney transplant recipients by one year post-transplantation

  up to one year after transplantation

Secondary Outcomes (7)

• Incidence of Leukopenia (defined as WBC < 2.5 x 103 cells/mm3 beyond the first 2 weeks of transplantation, while on pharmacologic CMV prophylaxis)

  From 2 weeks up to 26 weeks post-transplant

• Impact of Pharmacological Prophylaxis on CMV T-Cell immunity up to 1 year post-transplant

  up to 1 Year post-transplant

• Incidence of acute kidney allograft rejection up to one year after transplantation

  up to 1 Year post-transplant

• Impact of Pharmacologic CMV Prophylaxis on Mycophenolate dosage up to 6 months post-transplant

  Up to 6 months post-transplant

• Incidence of de novo donor specific antibody formation up to 1 year after transplant

  up to 1 Year post-transplant

Study Arms (2)

Letermovir group (study group)

EXPERIMENTAL

Letermovir 480 mg once daily

Drug: Letermovir 480 mg once daily

Historical Control study group

OTHER

Historically matched AA kidney transplant recipients who received the standard of care 450mg once a day valganciclovir prophylaxis

Other: Historical/Control

Interventions

Letermovir 480 mg once daily DRUG

We will test the study hypothesis in a single center, matched (1:1 fashion) pilot study of Letermovir 480 mg once daily versus historically matched AA kidney transplant recipients who received valganciclovir. We will enroll 30 AA patients over a 12-month period into the Letermovir group and compare outcomes to a historical group of 30 AA kidney transplant recipients who have received valganciclovir prophylaxis (1:1 fashion), for a total of 60 patients. We will attempt to match patients on Letermovir to the historical patients who received valganciclovir, based on age, kidney Donor profile index and the presence of panel of reactive antibodies.

Letermovir group (study group)

Historical/Control OTHER

The control study group will include high-risk African American kidney transplant recipients cared for with Valganciclovir in the 5 years prior to the enrollment start for the study group. This time frame is based upon the current volume of transplants done at VCU. On average 30 liver and/or kidney transplants are done per month. Thus, 5 years should be an adequate time frame to mine enough number of participants to answer our primary research hypothesis.

Historical Control study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kidney transplant recipients
• Male or female age ≥ 18 years old
• African American race
• CMV high risk (D+/R-)
• received valganciclovir for CMV prophylaxis
• Historical Control group:

You may not qualify if:

• Re-transplantation
• Panel of reactive antibody ≥80% at the time of transplant
• Positive cytotoxic cross match at the time of transplant
• Kidney transplant recipients
• Male or female age ≥ 18 years old
• African American race
• CMV high risk (D+/R-)
• Ability to provide informed consent before any trial related activities
• Re-transplantation
• Panel of reactive antibody ≥80% at the time of transplant
• Positive cytotoxic cross match at the time of transplant
• Pregnancy and Breastfeeding
• Prisoners
• Patients with hypersensitivity to acyclovir, valacyclovir or any of its components
• Patients with hypersensitivity to Letermovir or any of its components

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: collaborator
• Virginia Commonwealth University: lead

Study Sites (1)

VCU Medical Center

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Interventions

letermovir; Health Records, Personal

Intervention Hierarchy (Ancestors)

Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques

Study Officials

• Gaurav Gupta, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, Historical Controlled, Single Center Open Label Pilot Study

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 21, 2023
• Study Start: September 25, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)