Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial.
Ajit P Limaye, Klemens Budde, Atul Humar...
https://pubmed.ncbi.nlm.nih.gov/37279999Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID06798909
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
26 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
Researchers are evaluating two strategies to prevent cytomegalovirus (CMV) disease in adult kidney transplant recipients who received an organ from a CMV-positive donor but are themselves CMV-negative. This prospective, randomized, multicenter Phase 3 trial compares preemptive therapy (PET) to antiviral prophylaxis (AP) to see which is more effective in preventing CMV disease. Approximately 360 participants will be enrolled and followed for up to 5.5 years post-transplant to assess clinical, laboratory, immunologic, and safety outcomes. Participants will be randomly assigned within 7 days of transplant to either receive antiviral prophylaxis with oral valganciclovir once daily or letermovir once daily for 200 days post-transplant, or to preemptive therapy involving weekly blood tests to monitor CMV DNA levels for 100 days post-transplant. Those in the preemptive therapy group will start oral valganciclovir twice daily only if CMV DNA is detected and continue until two consecutive weekly tests show no viral DNA. Doses are adjusted according to kidney function. During the study, participants will undergo regular blood tests to monitor CMV levels, kidney function, and immune response, as well as assessments for any CMV disease or complications. The main outcome measured is the incidence of confirmed CMV disease within one year after transplant. Other outcomes include time to acute rejection, graft loss, death, and kidney function over several years. Participants will be followed until withdrawal, death, or study closure, with ongoing safety monitoring throughout.
CONDITIONS
Brief Title
Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Age 18 years or older at time of consent
- Negative for CMV IgG antibody between 28 days before transplant and up to 7 days after transplant but before randomization
- Received a kidney transplant from a CMV seropositive donor within 7 days prior to enrollment
- Negative pregnancy test before randomization if of reproductive potential
- Agree to use medically approved contraception during the intervention period if of reproductive potential
- Male participants must agree to use barrier contraception or abstinence during the intervention period
You will not qualify if you...
- Unable or unwilling to undergo 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 last 3 months
- Enrolled or planning enrollment in another interventional study that may affect outcomes
- Platelet count less than 25,000/uL post-transplant
- Absolute neutrophil count less than 1000/uL post-transplant
- Multi-organ transplant (except simultaneous kidney-pancreas) within past 7 days
- Prior or planned hematopoietic cell transplant
- Known or suspected immunodeficiency including HIV infection
- Unacceptable immunosuppression such as desensitization therapy before transplant or ABO-incompatible kidney transplant except A2 to blood type B
AI-Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 200 days post transplantation
Participants receive Valganciclovir either as pre-emptive therapy after detection of CMV viremia or as prophylaxis daily for 200 days post kidney transplant.
Weekly visits for CMV PCR testing in Pre-emptive Therapy group; daily medication intake in Prophylaxis group
Follow-up
Duration - Up to 1 year post transplantation
Participants are monitored for CMV disease, graft function, and overall health outcomes up to 1 year post-transplant.
Regular follow-up visits scheduled as per clinical care
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
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Research Team
M
Megan Gish
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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Published Research Related To This Trial
The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation.
Camille N Kotton, Deepali Kumar, Angela M Caliendo...
https://pubmed.ncbi.nlm.nih.gov/29596116