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NCT06798909 · ClinicalTrials.gov registry record · Phase 3
Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients
A Phase 3 study of Kidney Diseases and Kidney Transplant; Complications, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 360
- Enrollment target
- 5
- Study locations
NCT06798909: Recruiting Phase 3 study of Kidney Diseases and Kidney Transplant; Complications, sponsored by University of California, San Francisco.
NCT06798909 is a Phase 3 study of Kidney Diseases and Kidney Transplant; Complications that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 360 participants, below the 1,776-participant average among 38 other Kidney Diseases trials with a reported enrollment target (80% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06798909, a Phase 3 study of Kidney Diseases and Kidney Transplant; Complications, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 360 participants
- Enrollment target
- 5
- Study locations
Study Summary
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 Studied
Interventions
- DRUG Valganciclovir (Pre-emptive CMV Therapy)
- DRUG Valganciclovir CMV Prophylaxis
Study Locations (5)
California
- University of California, San Francisco School of Medicine - San Francisco
Florida
- University of Miami Miller School of Medicine - Miami
Georgia
- Emory University School of Medicine - Atlanta
New Jersey
- Robert Wood Johnson Health Network Barnabas Health - Livingston
Virginia
- Medical College of Virginia Commonwealth - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2025-07-22 |
| Est. Completion | 2031-06-30 |
| Phase | Phase 3 |
What NCT06798909 shows while recruiting
NCT06798909 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, below the 1,776-participant average among 38 other Kidney Diseases trials with a reported enrollment target (80% lower).
The record links to 3 conditions, with Kidney Diseases appearing as the primary indexed condition, and to 2 interventions - of which Valganciclovir (Pre-emptive CMV Therapy) is the first listed.
NCT06798909 lists 5 locations in 5 states (California, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT06798909 about?
NCT06798909 is a clinical study titled "Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients". 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 ...
What is the current status of trial NCT06798909?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 360 participants. The study started on 2025-07-22. Estimated completion is 2031-06-30.
What conditions does trial NCT06798909 study?
This clinical trial studies the following conditions: Kidney Diseases, Kidney Transplant; Complications, Cytomegalovirus (CMV).
What interventions are being tested in trial NCT06798909?
The interventions under investigation include: Valganciclovir (Pre-emptive CMV Therapy) (DRUG), Valganciclovir CMV Prophylaxis (DRUG).
Who is sponsoring clinical trial NCT06798909?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06798909 being conducted?
This trial has 5 study locations across California, Florida, Georgia, New Jersey, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06798909's enrollment target sits among peer trials
360 11th of 38 higher than 28 of 38 other Kidney Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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