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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.

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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.

Interventions

  • DRUG Letermovir 480 mg once daily
  • OTHER Historical/Control

Study Locations (1)

Virginia

  • VCU Medical Center - Richmond

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2023-09-25
Est. Completion 2026-09-01
Phase Phase 3

Sponsor

Virginia Commonwealth University

558 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.