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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

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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

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 05 Mar 2025

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At a glance

  • Drugs Citrate/heparin/taurolidine (Primary) ; Heparin
  • Indications Catheter infections
  • Focus Registrational; Therapeutic Use
  • Acronyms LOCK-IT-100
  • Sponsors CorMedix

Most Recent Events

  • 11 Apr 2024 According to a CorMedix media release, company announced abstract from this study has been accepted for presentation at the Society for Healthcare Epidemiology of America (SHEA) conference being held in Houston, Texas, April 16 - 19, 2024.
  • 15 Nov 2023 According to a CorMedix media release, based on this study data, the U.S. Food and Drug Administration (FDA) has approved DefenCath (taurolidine and heparin) catheter lock solution (CLS) to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC).
  • 01 Nov 2023 Results comparing the efficacy and safety of a taurolidine/heparin catheter lock solution that combines taurolidine 13.5 mg/ml and heparin (1000 units/ml) versus heparin in preventing CRBSIs in participants receiving hemodialysis via CVC, published in the Clinical Journal of The American Society of Nephrology: CJASN

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