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

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status and phase

Enrolling
Early Phase 1

Conditions

Kidney Transplant; Complications
CMV

Treatments

Other: Historical/Control
Drug: Letermovir 480 mg once daily

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06001320
HM20027540

Details and patient eligibility

About

CMV viremia will be treated with either oral valganciclovir, intravenous ganciclovir or alternative agents, according to AST ID COP (American Society of Transplantation Infectious disease community of practice) guidelines.

Full description

Intervention: Letermovir prophylaxis. Prophylaxis is once daily dose of Letermovier starting Day 1 of post-transplant up until 6 months post-transplant. Participants enrolled in this study will also receive prophylactic acyclovir 400mg twice daily for the duration of their Letermovir treatment. Strategy for CMV Viremia: CMV viremia will be treated with either oral valganciclovir, intravenous ganciclovir or alternative agents, according to AST ID COP (American Society of Transplantation Infectious disease community of practice) guidelines.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Historical Control group:

Inclusion Criteria

  • 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:

Exclusion

  • Re-transplantation
  • Panel of reactive antibody ≥80% at the time of transplant
  • Positive cytotoxic cross match at the time of transplant

Experimental Group Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • If Patients are taking any of these medications: pimozide, ergot alkaloids (ergotamine, dihydroergotamine), or pitavastatin/simvastatin co-administered with cyclosporine, we will work with the prescribing physician to find an appropriate replacement therapy which will not interfere with any study-related interventions. Otherwise, participants will be excluded from the study.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Letermovir group (study group)
Experimental group
Description:
Letermovir 480 mg once daily
Treatment:
Drug: Letermovir 480 mg once daily
Historically matched AA kidney transplant recipients who received valganciclovir
Other group
Description:
Compare outcomes to a historical group of 50 AA kidney transplant recipients who have received valganciclovir prophylaxis
Treatment:
Other: Historical/Control

Trial contacts and locations

0

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Central trial contact

Idris Yakubu, PharmD; Gelila Abebe

Data sourced from clinicaltrials.gov

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