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NCT01624948 · ClinicalTrials.gov registry record · Phase 4

Safety and Efficacy Study of Everolimus to Treat BK Virus Infection in Kidney Transplant Recipients

A Phase 4 study of BK Virus Infection, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 4
Development phase
40
Enrollment target
1
Study location

NCT01624948 is a Phase 4 study of BK Virus Infection that has completed, run by University of California, San Francisco. The registered enrollment target is 40 participants, below the 74-participant average among 6 other BK Virus Infection trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01624948, a Phase 4 study of BK Virus Infection, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 4
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

This study is examining the safety and efficacy of converting anti-rejection therapy from mycophenolic acid (MPA) to Zortress (everolimus) in renal transplant recipients with BK virus infection. The study will also determine if immune monitoring tests can detect an association between BK virus infection and transplant rejection episodes, based on the specific BKV infection treatment regimen. The investigators hypothesize that an anti-rejection regimen with Zortress (everolimus) and tacrolimus + prednisone will be superior to a standard regimen of reduced dose MPA and tacrolimus + prednisone in patients who have undergone renal transplantation and have active BKV infections.

Conditions Studied

BK Virus Infection

Interventions

  • DRUG Everolimus
  • DRUG Mycophenolic acid dose reduction

Study Locations (1)

California

  • University of California, San Francisco - San Francisco

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2012-09
Est. Completion 2015-11
Phase Phase 4

Sponsor

University of California, San Francisco

1,713 total trials

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What the Registry Record Tells You About NCT01624948

The ClinicalTrials.gov registry entry for NCT01624948 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 74-participant average among 6 other BK Virus Infection trials with a reported enrollment target (46% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with BK Virus Infection appearing as the primary indexed condition, and to 2 interventions - of which Everolimus is the first listed.

NCT01624948 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT01624948 about?

NCT01624948 is a clinical study titled "Safety and Efficacy Study of Everolimus to Treat BK Virus Infection in Kidney Transplant Recipients". This study is examining the safety and efficacy of converting anti-rejection therapy from mycophenolic acid (MPA) to Zortress (everolimus) in renal transplant recipients with BK virus infection. The study will also determine if immune monitoring tests can detect an association between BK virus infe...

What is the current status of trial NCT01624948?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2012-09. Estimated completion is 2015-11.

What conditions does trial NCT01624948 study?

This clinical trial studies the following conditions: BK Virus Infection.

What interventions are being tested in trial NCT01624948?

The interventions under investigation include: Everolimus (DRUG), Mycophenolic acid dose reduction (DRUG).

Who is sponsoring clinical trial NCT01624948?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01624948 being conducted?

This trial has 1 study location across California. 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.