drugset / Trial / NCT06714864

Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age

NCT06714864

Phase 4 Recruiting 36 enrolled CorMedix
RandomizedParallel-groupOpen-labelPrevention

Summary

This study is a post-marketing approval requirement to assess the safety and time to Catheter-related Bloodstream Infections (CRBSI) of DefenCath in pediatric population (birth to less than 18 years of age) who are on chronic HD for kidney failure.

Timeline

Start
2025-07-08
Primary completion
2028-07
Completion
2029-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Heparin Other / unclassified Other
Subject taurolidine Small molecule Other