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

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Eligibility criteria expanded, about 39 words
    • Site details revised at 4 of 6 sites
  2. Sponsor changed: CorMedix to CorMedix Therapeutics
    • Eligibility criteria shortened, about 52 words
    v11
  3. Primary completion date: Jan 2026 to Jul 2028
    • Study sites: 4 to 6
    • Study completion date: Mar 2026 to Apr 2029
    v10
  4. Study sites: 3 to 4v9
  5. Site details revised at 2 of 3 sitesv8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 1 to 3v7
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2025 to Jul 8, 2025
    • Site details revised
    v6
  3. Start date: May 2025 to Jul 2025
    • Study sites: 0 to 1
    v5
  4. Start date: Apr 2025 to May 2025v4
  5. Start date: Dec 2024 to Apr 2025v3
  6. Primary endpoints revised (2)
    • Eligibility criteria expanded, about 4 words
    • Study title expanded, about 2 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06714864
Lead Sponsor CorMedix Therapeutics
Conditions
(from sponsor)		 Catheter-Related Infections
Related terms Catheter-Related Infections
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov