Condition: Cytomegalovirus (CMV) · Kidney Transplant; Complications · Kidney Diseases · Sponsor: University of California, San Francisco
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
This description comes directly from the study's public registry record.
Megan Gish · 415-476-1985 · megan.gish@ucsf.edu
Always discuss trial participation with your own doctor first.
| 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 |
| Medical College of Virginia Commonwealth | Richmond, Virginia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06798909