MedTrace Logo

Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection

NCT02651428 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 806

Last updated 2025-02-25

Study results available
· View outcomes & findings →

Summary

The purpose of this study is determine safety and effectiveness of Neutrolin, a catheter lock solution, for prevention of central venous catheter associated bloodstream infection in hemodialysis patients.

Conditions

  • Kidney Failure, Chronic
  • Catheter-Related Infections

Interventions

DRUG

Neutrolin

Neutrolin® will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session

DRUG

Heparin

Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • JMI Laboratories

    collaborator INDUSTRY

  • Spectra Clinical Research

    collaborator OTHER

  • Davita Clinical Research

    collaborator INDUSTRY

  • Frenova Renal Research

    collaborator OTHER

  • CorMedix

    lead INDUSTRY

Principal Investigators

  • Antony Pfaffle, MD · Chief Scientific Officer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-10-31
Completion
2018-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02651428 on ClinicalTrials.gov