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Label indication LIMITED POPULATION: DEFENCATH ® is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients [see Clinical Studies (14) ]. FDA label
Also known as catheter lock
DefenCath · 1 trial · 1 indication
The proportion of participants who remain infection-free in the treatment groups will be compared, censoring participants who do not experience a CLABSI, but fail to complete the 12-month follow-up period of the study.
| Arm | Type | Description |
|---|---|---|
| DefenCath® | EXPERIMENTAL | - |
| Control | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| (taurolidine and heparin) catheter lock solution | DRUG | for central venous catheter installation use |
| Heparin | DRUG | Heparin |
1. Participants who are resident within study site's country. 2. Participants who are male or female, aged ≥12 years at the time of consent. 3. Participants must sign and provide informed consent. For adolescent participants or participants that require a legal representative, written informed conse...
DefenCath is a catheter lock solution being studied to reduce central line associated bloodstream infections, or CLABSIs, in adults and adolescents who receive total parenteral nutrition through a central venous catheter. It is an investigational product in Phase 3 development for this infectious disease indication.
DefenCath is developed by CorMedix Inc., which trades on the Nasdaq under the ticker CRMD. The company is the sponsor of the clinical program evaluating the catheter lock solution in patients receiving total parenteral nutrition through a central venous catheter.
DefenCath is in Phase 3 clinical development. The program is investigating whether the catheter lock solution reduces central line associated bloodstream infections in adults and adolescents receiving total parenteral nutrition through a central venous catheter. It remains an investigational product and is not approved for this use.
DefenCath is being evaluated in the Phase 3 trial NCT06822426, titled Comparing The Safety And Efficacy Of DEFENCATH In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults And Adolescent Participants Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC). The trial is recruiting and plans to enroll 200 participants in the United States and Turkey.
Yes. DefenCath is also known as a taurolidine and heparin catheter lock solution, and is sometimes referred to simply as a catheter lock. These names describe the same product being developed by CorMedix for reducing central line associated bloodstream infections in patients receiving total parenteral nutrition through a central venous catheter.
Trial NCT06822426 is a randomized, double-blind, active-controlled Phase 3 study of DefenCath in patients aged 12 years and older receiving total parenteral nutrition through a central venous catheter. It is recruiting 200 participants across the United States and Turkey, and healthy volunteers are not eligible.