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

Trial Profile

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Aug 2017

At a glance

  • Drugs Citrate/heparin/taurolidine (Primary)
  • Indications Bacterial infections; Catheter infections; Catheter thrombosis; Mycoses
  • Focus Registrational; Therapeutic Use
  • Acronyms LOCK-IT-100
  • Sponsors CorMedix
  • Most Recent Events

    • 09 Aug 2017 According to a CorMedix media release, completion of enrollment is anticipated by 2Q18 and top-line data will be available in the second half of 2018.
    • 02 Aug 2017 According to a company media release, CorMedix believes the changes will allow the identification of more infections, enabling a single interim analysis, which is anticipated to occur in the fourth quarter of 2017, based on 28 CRBSI events. Should the interim analysis show sufficient efficacy it may be possible to conclude the study earlier than projected.
    • 02 Aug 2017 According to a CorMedix media release, the company has revised the design of the study to detect a treatment effect of 55% or greater when comparing the Neutrolin and heparin control arms.The amended study assumptions, including a reduction in statistical power, have resulted in a reduction in the total number of CRBSI events required from 161 events to 56 events to complete the study.
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