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

PHASE3RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 25, 2023

Primary Completion Date

December 1, 2025

Study Completion Date

September 1, 2026

Conditions
Kidney Transplant; ComplicationsCMV
Interventions
DRUG

Letermovir 480 mg once daily

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.

OTHER

Historical/Control

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.

Trial Locations (1)

23219

RECRUITING

VCU Medical Center, Richmond

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Virginia Commonwealth University

OTHER