Cormedix Inc. ((CRMD)) announced an update on their ongoing clinical study.
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CorMedix Inc. is conducting an open-label study titled ‘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.’ The study aims to evaluate the safety and effectiveness of DefenCath® in preventing catheter-related bloodstream infections in pediatric patients undergoing hemodialysis due to kidney failure.
The intervention being tested is a catheter lock solution containing taurolidine and heparin, known as DefenCath®. This solution is compared against the institutional standard of care to determine its efficacy in reducing infection rates.
This interventional study is designed as a randomized, parallel-assignment trial with no masking, focusing primarily on prevention. The study is in Phase 4, indicating it is conducted after the product has been marketed to gather additional information on the drug’s effect in various populations.
The study began on December 2, 2024, with the latest update submitted on September 3, 2025. These dates are crucial as they mark the progression and current status of the trial, which is still recruiting participants.
The outcome of this study could significantly impact CorMedix Inc.’s market position, potentially boosting investor confidence if the results are favorable. The success of DefenCath® could influence stock performance positively, especially in comparison to competitors in the catheter-related infection prevention market.
The study is ongoing, and further details can be accessed on the ClinicalTrials portal.