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NCT01734694 · ClinicalTrials.gov registry record · Phase 4

Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients

A Phase 4 study, sponsored by Henry Ford Health System.

Terminated
Registry status
Phase 4
Development phase
100
Enrollment target

NCT01734694: Clinical Trial Phase 4 study, sponsored by Henry Ford Health System.

NCT01734694 is a Phase 4 study that was terminated before completion, run by Henry Ford Health System. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01734694, a Phase 4 study, was terminated before completion, sponsored by Henry Ford Health System.

TERMINATED
Registry status
Phase 4
Development phase
100 participants
Enrollment target

Study Summary

For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.

Primary Outcome

Increase in SCr of 0.5 mg/dL or 50% above baseline for at least two consecutive days while on the study drug and through discharge from hospital. This measure will be reported as proportion of patients with nephrotoxicity within each group in relation to the number of patients in each group.

Interventions

  • DRUG Vancomycin
  • DRUG Ceftaroline
  • DRUG Linezolid
  • DRUG Daptomycin

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2011-10
Est. Completion 2012-09
Phase Phase 4
Henry Ford Health System

234 total trials

Why NCT01734694 stopped before completion

NCT01734694 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 4 interventions - of which Vancomycin is the first listed.

NCT01734694 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01734694 about?

NCT01734694 is a clinical study titled "Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients". For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due...

What is the current status of trial NCT01734694?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2011-10. Estimated completion is 2012-09.

What interventions are being tested in trial NCT01734694?

The interventions under investigation include: Vancomycin (DRUG), Ceftaroline (DRUG), Linezolid (DRUG), Daptomycin (DRUG).

Who is sponsoring clinical trial NCT01734694?

This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01734694's enrollment target sits among peer trials

100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT01734694, the US trial registry maintained by the National Library of Medicine. NCT01734694 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.