Trials / Recruiting
RecruitingNCT06714864
Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age
An Open-Label, Two-Arm (DefenCath® vs. Institutional Standard of Care) Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to Less Than 18 Years of Age With Kidney Failure Receiving Hemodialysis Via a Central Venous Catheter
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- CorMedix · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | (taurolidine and heparin) catheter lock solution | for central venous catheter instillation use |
| DRUG | Standard of Care | Site specific standard of care |
Timeline
- Start date
- 2025-07-08
- Primary completion
- 2026-01-01
- Completion
- 2026-03-01
- First posted
- 2024-12-04
- Last updated
- 2025-11-04
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06714864. Inclusion in this directory is not an endorsement.