Actively Recruiting
Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients
Led by University of California, San Francisco · Updated on 2026-04-01
360
Participants Needed
5
Research Sites
305 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject or legally authorized representative has provided written informed consent.
- Age 18 years or older at the time of informed consent.
- Negative for IgG antibody to CMV between 28 days prior to transplant and up to 7 days post-transplant but before randomization.
- Received a kidney transplant from a CMV seropositive (IgG positive) donor within 7 days prior to enrollment.
- Individuals of reproductive potential must have a negative pregnancy test before randomization and agree to use medically approved contraception or abstain during the intervention period.
- Males must agree to use barrier contraception or abstain from enrollment through 3 months after stopping valganciclovir or ganciclovir during the intervention period.
You will not qualify if you...
- Unable or unwilling to follow the preemptive therapy protocol (weekly CMV PCR testing).
- Breastfeeding or planning to breastfeed within 6 months post-transplant.
- Allergy to valganciclovir, ganciclovir, or letermovir.
- Received immunoglobulin or CMV-specific immunoglobulin within the last 3 months.
- Enrolled or planning enrollment in another interventional study that may affect safety or efficacy outcomes.
- Platelet count below 25,000/uL post-transplant.
- Absolute neutrophil count below 1000/uL post-transplant.
- Multi-organ transplant within past 7 days, except simultaneous kidney-pancreas.
- Prior or planned hematopoietic cell transplant.
- Baseline immunodeficiency including known/suspected HIV or congenital/acquired immunodeficiency.
- Unacceptable immunosuppression such as desensitization therapy prior to transplant or ABO-incompatible kidney transplant except A2 to blood type B.
AI-Screening
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Trial Site Locations
Total: 5 locations
1
University of California, San Francisco School of Medicine
San Francisco, California, United States, 94117
Actively Recruiting
2
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
3
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Robert Wood Johnson Health Network Barnabas Health
Livingston, New Jersey, United States, 07039
Actively Recruiting
5
Medical College of Virginia Commonwealth
Richmond, Virginia, United States, 23219
Actively Recruiting
Research Team
M
Megan Gish
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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