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NCT06001320 · ClinicalTrials.gov registry record · Phase 3
De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
A Phase 3 study of Kidney Transplant; Complications and CMV, sponsored by Virginia Commonwealth University.
- Active
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06001320: Active Phase 3 study of Kidney Transplant; Complications and CMV, sponsored by Virginia Commonwealth University.
NCT06001320 is a Phase 3 study of Kidney Transplant; Complications and CMV that is active but no longer recruiting, run by Virginia Commonwealth University. The registered enrollment target is 60 participants, below the 119-participant average among 19 other Kidney Transplant; Complications trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06001320, a Phase 3 study of Kidney Transplant; Complications and CMV, is active but no longer recruiting, sponsored by Virginia Commonwealth University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being done to compare the effectiveness of de novo Letermovir versus valganciclovir in preventing the development of cytomegalovirus viremia or symptomatic disease in African American kidney transplant recipients within the first year after transplantation. There are two arms in the study: Arm 1: Prophylaxis: This group includes freshly transplanted high risk (CMV D+/R-) African American Kidney recipients who will be on prophylactic Letermovir for 6 month. Arm 2: Prophylaxis: This group includes high-risk African American kidney transplant recipients who had already completed the 6 month prophylactic course with the standard of care Valganciclovir.
Primary Outcome
The incidence of cytomegalovirus viremia (defined as CMV PCR \> 137 units/ml) or symptomatic disease in AA kidney transplant recipients by one year post-transplantation
Conditions Studied
Interventions
- DRUG Letermovir 480 mg once daily
- OTHER Historical/Control
Study Locations (1)
Virginia
- VCU Medical Center - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-09-25 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 3 |
What the registry record for NCT06001320 still lists
NCT06001320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 119-participant average among 19 other Kidney Transplant; Complications trials with a reported enrollment target (50% lower).
The record links to 2 conditions, with Kidney Transplant; Complications appearing as the primary indexed condition, and to 2 interventions - of which Letermovir 480 mg once daily is the first listed.
NCT06001320 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT06001320 about?
NCT06001320 is a clinical study titled "De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients". This study is being done to compare the effectiveness of de novo Letermovir versus valganciclovir in preventing the development of cytomegalovirus viremia or symptomatic disease in African American kidney transplant recipients within the first year after transplantation. There are two arms in the s...
What is the current status of trial NCT06001320?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2023-09-25. Estimated completion is 2026-09-01.
What conditions does trial NCT06001320 study?
This clinical trial studies the following conditions: Kidney Transplant; Complications, CMV.
What interventions are being tested in trial NCT06001320?
The interventions under investigation include: Letermovir 480 mg once daily (DRUG), Historical/Control (OTHER).
Who is sponsoring clinical trial NCT06001320?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06001320 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Transplant; Complications
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 NCT06001320's enrollment target sits among peer trials
60 13th of 19 higher than 5 of 19 other Kidney Transplant; Complications trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplant; Complications 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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-
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