Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06798909
Phase
PHASE3
Status
Recruiting
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Conditions

  • Cytomegalovirus (CMV)
  • Kidney Diseases
  • Kidney Transplant; Complications

Eligibility Criteria

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

Interventions

  • Valganciclovir (Pre-emptive CMV Therapy) — DRUG
    Valganciclovir, 900 mg given orally twice daily to Preemptive Therapy group subjects as a PET only after a positive CMV PCR test and stopped after PCR is negative for 2 consecutive weeks.
  • Valganciclovir CMV Prophylaxis — DRUG
    Valganciclovir, 900 mg given orally once daily to all Prophylaxis group subjects for 200 days post transplantation as prophylaxis.

Study Details

This is a prospective, randomized multicenter trial of preemptive therapy (PET) vs. antiviral prophylaxis (AP) for prevention of cytomegalovirus (CMV) disease in adult D+R- kidney transplant recipients (KTR). Patients meeting study eligibility criteria and who have provided informed consent will be randomized (1:1) within 7 days of transplant to receive, in an open label design, either AP with valganciclovir 900 mg orally once daily or letermovir 480 mg orally once daily \[both dose adjusted per Food and Drug Administration (FDA) label\] for 200 days post-transplant), or PET (central lab weekly plasma polymerase chain reaction (PCR) monitoring for CMV deoxyribonucleic acidemia (DNAemia)) for 100 days post-transplant, with oral valganciclovir 900mg orally twice daily (or renally dosed per FDA label) at onset of CMV DNAemia at any level and continued until plasma CMV DNAemia is negative or below the level of quantitation in two consecutive weekly plasma samples. Study participants will be followed for pre-specified outcomes (clinical, laboratory, immunologic, safety) until withdrawal, death, or study closure, up to a maximum of 5.5 years post-transplant. Approximately 360 participants (180 participants in each group) will be randomized into the study. Estimated Time to Complete Enrollment: 4 years

Key Dates

Start date
Jul 22, 2025
Status verified
Mar 2026
Primary completion
Nov 30, 2030
Completion
May 31, 2031

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Pre-emptive Therapy
    900 mg of Valganciclovir given orally twice daily to Preemptive Therapy subjects upon detection of CMV viremia until plasma PCR is negative on two consecutive weekly PCR test. All dosages adjusted for renal dysfunction.
  • Active Comparator: Prophylaxis
    900 mg of Valganciclovir given orally once daily to subjects for 200 days post transplantation. All dosages adjusted for renal dysfunction.

Primary Outcome Measure

Incidence of endpoint committee (EC)-confirmed CMV disease (either syndrome or end-organ) by 1-year post-transplant. [ Time Frame: Within 1-year post-transplant ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California, San Francisco School of MedicineSan FranciscoCalifornia94117
Puneet Sood, MD, MPH
[email protected]
415-353-1551
University of Miami Miller School of MedicineMiamiFlorida33136
Yoichiro Natori, MD
[email protected]
305-355-5418
Emory University School of MedicineAtlantaGeorgia30322
Aneesh Mehta, MD
[email protected]
404-727-8435
Robert Wood Johnson Health Network Barnabas HealthLivingstonNew Jersey07039
Francis Weng, MD
[email protected]
973-322-5065
Medical College of Virginia CommonwealthRichmondVirginia23219
Guarav Gupta, MD
[email protected]
804-828-4104

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University of California, San Francisco School of Medicine· San Francisco, CAUniversity of Miami Miller School of Medicine· Miami, FLEmory University School of Medicine· Atlanta, GARobert Wood Johnson Health Network Barnabas Health· Livingston, NJMedical College of Virginia Commonwealth· Richmond, VA

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