CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 806 enrolled
Drug / intervention
Neutrolin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02651428
NCT02651428Phase 3Completed
CompareCT.gov

Phase 3 Prospective, Multicenter, Double-blind, Randomized, Active Control Study to Demonstrate Safety & Effectiveness of Neutrolin in Preventing Catheter-related Bloodstream Infection in Subjects on Hemodialysis for End Stage Renal Disease

CorMedix·interventional·Posted Jan 11, 2016·Updated Feb 25, 2025

In Brief

A Phase 3 clinical trial evaluating Neutrolin and Heparin for Kidney Failure, Chronic and Catheter-Related Infections. Completed, enrolled 806 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Failure, Chronic, Catheter-Related Infections
CountriesUnited States
CollaboratorsPPD Development, LP, JMI Laboratories, Spectra Clinical Research, Davita Clinical Research, Frenova Renal Research

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 11, 2016
Enrollment StartDec 1, 2015
Primary CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.5 years ago

Interventions

Neutrolindrug

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will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session

Heparindrug

Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session