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Clinical trial Recruiting at 6 sites Phase 3 Interventional Ages 18 and up

Preventing CMV after receiving a CMV-positive donor kidney using daily antiviral pills or weekly blood monitoring

Official title: Kidney Transplant Preemptive Therapy or Prophylaxis (KPoP) for CMV Prevention in D+R- Recipients

Run by University of California, San Francisco · NCT06798909 · Data updated 2026-11-12

This study will test whether taking daily antiviral pills for 200 days or doing weekly blood checks and treating only if the virus appears is better at preventing CMV disease in adults who get a kidney from a CMV-positive donor and are themselves CMV-negative.

More Kidney Transplant trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment360 (estimated)
SponsorUniversity of California, San Francisco
Academic / other
Locations8 sites (San Francisco, California and 7 other locations)
StatusRecruiting
StartedJuly 22, 2025
Main results expectedNovember 30, 2030
Study endsMay 31, 2031
Registry record updatedNovember 2, 2026
Trial IDNCT06798909 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 or older who are CMV IgG negative, received a kidney from a CMV IgG positive donor within the past 7 days, provided informed consent, and meet pregnancy-testing and contraception requirements are eligible.

Probably not a fit

People who are CMV-seropositive, received non-kidney organs, have contraindications to the study antivirals, or cannot comply with study monitoring are unlikely to benefit from participating.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, open-label, multicenter Phase 3 trial that enrolls adult CMV-seronegative recipients of CMV-seropositive donor kidneys and randomizes them 1:1 within 7 days of transplant. One arm receives antiviral prophylaxis (valganciclovir 900 mg once daily or letermovir 480 mg once daily, dose-adjusted per FDA labeling) for 200 days post-transplant. The other arm follows a preemptive strategy with weekly central-laboratory plasma CMV PCR monitoring for 100 days and starts oral valganciclovir 900 mg twice daily (renally dosed per label) only if CMV DNAemia is detected, continuing until two consecutive weekly negatives. The trial compares the two approaches for prevention of CMV disease and related complications in this high-risk donor-positive/recipient-negative population.

Why it matters

Potential benefit: If successful, this approach could reduce CMV disease and related complications after high-risk kidney transplants, potentially lowering hospital stays and protecting the transplanted kidney.

How similar studies have gone: Previous randomized and observational work in solid-organ transplantation has shown that antiviral prophylaxis reduces CMV disease compared with no prophylaxis and that preemptive strategies can also be effective, while letermovir is a newer agent with stronger evidence in stem-cell transplant settings and emerging data in solid-organ transplant.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Subject has provided written informed consent.
2. Age ≥ 18 years of age at the time of informed consent.
3. Negative for IgG antibody to CMV as assessed in a CLIA-certified laboratory between 28 days prior to transplant and up to 10 days post-transplant but prior to randomization.
4. Received a kidney transplant from a CMV seropositive (IgG positive) donor in the past 10 days prior to enrollment
5. Individuals of reproductive (childbearing) potential must have a negative pregnancy test (serum or urine) collected prior to randomization (SOC results within 7 days prior to transplant may be used), and must also agree to use a medically approved method of contraception. Acceptable methods include: barrier method, intrauterine device (hormonal or non-hormonal), oral hormonal contraceptives, abstinence from the time of enrollment through until discontinuation of ganciclovir or valganciclovir in either arm during the intervention period.

   NOTE: Individuals of reproductive potential are defined as individuals who have reached menarche and who have not been post-menopausal for at least 12 consecutive months with follicle stimulating hormone (FSH) ≥40 IU/mL or 24 consecutive months if an FSH is not available, i.e., who have had menses within the preceding 24 months, and have not undergone a sterilization procedure (e.g., hysterectomy, bilateral oophorectomy, or salpingectomy).
6. If male, must agree to practice a barrier method of contraception or abstinence from the time of enrollment through 3 months after discontinuation of ganciclovir or valganciclovir in either arm during the intervention period.

Exclusion Criteria:

1. In the opinion of the investigator, participants who are unable or unwilling to undergo preemptive therapy protocol (weekly CMV PCR, etc.)
2. Patients who are breastfeeding or planning to breastfeed within 6 months post-transplant
3. Allergy to valganciclovir/ganciclovir or Letermovir
4. Receipt of immunoglobulin or CMV-specific immunoglobulin within the last 3 months prior to the qualifying CMV IgG serology as described in inclusion criteria #3 (this includes COVID convalescent plasma)
5. Currently enrolled or anticipated enrollment in another interventional study that, in the opinion of scientific leadership team, could affect evaluation of the primary safety and/or efficacy outcomes.
6. Most recent platelet count post-transplant \<25,000/uL
7. Most recent ANC performed post-transplant \<1000/uL
8. Multi-organ transplant (except simultaneous kidney-pancreas) within the past 7 days
9. Prior or planned receipt of a hematopoietic cell transplant
10. Baseline immunodeficiency prior to transplant, including but not limited to:

    1. Known or suspected HIV infection
    2. Congenital or acquired immunodeficiency
11. Unacceptable immunosuppression

    1. Receipt of desensitization therapy prior to kidney transplant, or
    2. Receipt of an ABO-incompatible kidney transplant except A2 to blood type B

Where it's running

  • University of California, San Francisco School of Medicine
    San Francisco, California, United States     Recruiting
  • University of Miami Miller School of Medicine
    Miami, Florida, United States     Recruiting
  • Emory University School of Medicine
    Atlanta, Georgia, United States     Recruiting
  • Robert Wood Johnson Health Network Barnabas Health
    Livingston, New Jersey, United States     Recruiting
  • Duke University
    Durham, North Carolina, United States     Recruiting
  • Medical College of Virginia Commonwealth
    Richmond, Virginia, United States     Recruiting
Show 2 more locations
  • University of Nebraska Medical Center
    Omaha, Nebraska, United States     Not yet recruiting
  • University of Texas Southwestern
    Dallas, Texas, United States     Not yet recruiting

Study contacts

  • Principal investigator: Abhijit P. Limaye, MD — University of California, San Francisco
  • Study coordinator: Megan Gish
  • Email: megan.gish@ucsf.edu
  • Phone: 415-476-1985

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
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Cytomegalovirus (CMV) 7Kidney Transplant 133Kidney Diseases 52University of California, San Francisco 3127
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.