Letermovir vs Valganciclovir in CMV R+ Kidney Transplant

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Elisabeth Kincaide
Study ID
NCT07571135
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • CMV
  • CMV Disease
  • CMV Infection
  • CMV Viremia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Letermovir — DRUG
    Letermovir 480 mg PO daily or 240 mg PO daily (if on cyclosporine) for 90 days post kidney transplant
  • Valganciclovir CMV Prophylaxis — DRUG
    Valganciclovir 450 mg PO daily for 90 days post kidney transplant (Historical Control)

Study Details

The purpose of this study is to find out whether letermovir can help prevent cytomegalovirus (CMV) infection in kidney transplant recipients who are CMV seropositive. To do this, researchers will compare patients who received letermovir with a group of historical patients who received valganciclovir ("mini dose"). Both groups will be on CMV prophylaxis drug for 90 days post-transplant. The main question the study wants to answer is: • Does letermovir work as well as valganciclovir in preventing CMV infections during the first 12 months after a kidney transplant? The study will also look at other important questions: * Is letermovir easier for patients to tolerate than valganciclovir? * How long does it take for a CMV infection to appear in each group? * Are there differences in "breakthrough" CMV infections between the two medications? * For patients who develop CMV that becomes resistant to treatment, are the resistance patterns different between the two groups

Key Dates

Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Letermovir
    Prospective letermovir prophylaxis
  • Other: Valganciclovir
    Historical valganciclovir prophylaxis

Primary Outcome Measure

CMV Infection [ Time Frame: 12 months post kidney transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University HospitalSan AntonioTexas78229
Elisabeth Kincaide, PharmD
[email protected]
210-743-4086
Sean Moore, BSN, RN
[email protected]
210-475-2559

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By research site
University Hospital· San Antonio, TX

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