CorMedix Therapeutics has announced interim results for the ongoing real-world study being conducted in conjunction with US Renal Care’s use of DefenCath—a combined taurolidine and heparin catheter lock solution—in adult haemodialysis patients with central venous catheters.
CorMedix and US Renal Care commenced the real-world evidence study upon outpatient commercial launch in July 2024.
The study is designed to demonstrate the impact of the broad use of DefenCath in a real-world setting and prospectively assess rates of catheter-related bloodstream infections (CRBSI), as well as hospitalisations secondary to these infections. The study is designed to evaluate these data points for two years.
Currently, more than 3,000 patients per month are receiving DefenCath on a routine basis at US Renal Care facilities. CorMedix conducted a preliminary analysis of interim data for approximately 7,000 patients having received at least one dose of DefenCath in year one.
Based on CorMedix’s analysis of the data available through September 30 2025, compared to historical controls, use of DefenCath demonstrated an overall 72% reduction in CRBSI, and a 70% reduction in hospitalisations secondary to CRBSI, CorMedix reports in a press release. The company believes this represents a meaningful reduction in risk in some of the most vulnerable patients as well as a significant source of cost savings to the healthcare community and payors.
Joseph Todisco, chief executive officer of CorMedix, commented: “We are proud to announce interim results for our ongoing real-world evidence study with our partners at US Renal Care. As one of our earliest outpatient customers, they have undertaken a significant effort in working with us on this important long-term study and ensuring patient access to DefenCath to prevent CRBSIs in haemodialysis patients at risk. We are now utilising this data in discussions with customers and payers as we seek to broaden access to DefenCath and establish long-term reimbursement with Medicare Advantage.”
Geoffrey A Block, associate chief medical officer and senior vice president of clinical research and medial affairs at US Renal Care, stated: “Our organisation is deeply committed to advancing innovative therapies for our patients, and we are encouraged by the reduction in both serious infections and hospitalisations demonstrated in these preliminary results.”
Paul T Conway, vice president and chair of policy for the American Association of Kidney Patients (AAKP) and a 48-year kidney patient, commented: “Every kidney patient receiving haemodialysis understands the inherent and serious risks posed by catheter-related bloodstream infections, including repeat hospitalisations, exposure to powerful intravenous antibiotics, jeopardisation of their transplant readiness and increased mortality. As the largest kidney patient organisation in the nation, AAKP welcomes this new and compelling information about DefenCath and the opportunity to better protect highly vulnerable dialysis patients while simultaneously reducing infection incidents and hospital admissions. We believe this data also strongly reinforces the ongoing collaborations among healthcare providers, patient advocates and elected leaders committed to transforming status quo dialysis care by addressing the long-standing and unmet need for infection prevention measures that lower hospitalisations, reduce healthcare utilisation and limit costs to taxpayers.”
Secondary datapoints of missed treatment sessions, antibiotic utilisation, and tPA utilisation are also being assessed and may be announced with additional real-world evidence data in the future.
CorMedix believes these data from this large, prospective, ongoing real-world study further underscore the LOCK-IT 100 clinical study results on which the US Food and Drug Administration (FDA) approval of DefenCath for end-stage renal disease (ESRD) haemodialysis patients was based.
