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

StatusCompleted
PhasePhase 3
Started
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Record History

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  1. Primary endpoints: details revised at 1 of 1 entry Show 6 more changesShow less
    • Trial completed
    • Interventions: Historical/Control (Other), Letermovir 480 mg once daily (Drug) to Historical/Control (Other), Letermovir 480 mg once daily (Drug)
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 4 of 7 entries
    • Collaborators: details revised at 1 of 1 entry
    • Study description expanded, about 2 words
  2. Primary completion pushed from Mar 1, 2026 to Sep 1, 2026
    • Enrollment reduced: 60 → 30 participants
    v11
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 1, 2025 to Mar 1, 2026
    • Site details revised
    v10
  4. Primary completion date: Sep 1, 2025 to Dec 1, 2025v9
  5. Phase: Phase 4 to Phase 3v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study description expanded, about 21 wordsv7
  2. Phase: Early Phase 1 to Phase 4
    • Enrollment target: 100 to 60
    • Study description expanded, about 316 words
    • Study title revised
    v6
  3. Secondary endpoints revised (7)v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 1, 2023 to Sep 25, 2023
    v4
  5. Start date: Oct 1, 2023 to Nov 1, 2023v3
  6. Start date: Sep 1, 2023 to Oct 1, 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06001320
Lead Sponsor Virginia Commonwealth University
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Kidney Transplant; Complications, CMV
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov