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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06001320
The ClinicalTrials.gov registry entry for NCT06001320 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 119-participant average among 19 other Kidney Transplant; Complications trials with a reported enrollment target (50% lower). The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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