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CorMedix completed a multi-center Phase 3 clinical trial in hemodialysis patients with central venous catheters in the U.S. named, LOCK-IT-100. The trial was a randomized, double-blind, active control, parallel arm trial designed to demonstrate the efficacy and safety of DefenCath™ as a catheter lock solution for preventing catheter-related bloodstream infections, or CRBSIs, in subjects receiving hemodialysis therapy as treatment for end-stage renal disease.

LOCK-IT-100 was a randomized, double-blind, active control, multicenter study to assess the efficacy and safety of DEFENCATH™ to reduce CRBSIs in kidney failure patients

In the final analysis of 795 patients, a total of 41 CRBSI events were determined by an independent, external Clinical Adjudication Committee (CAC), 32 in the control group vs. 9 in the DefenCath™ arm indicating a 71% reduction in the risk of occurrence of CRBSIs. In the DefenCath™ arm, the CRBSI event rate was 0.13 per 1000 catheter days, which is significantly lower than the event rate of 0.46 per 1000 catheter days in the control arm (p=0.0006).

*Cox Proportional Hazards Mode
Log-Rank Test
Reference: Data on file. CorMedix Inc.

During the clinical trial, there were no serious treatment-emergent adverse events (TEAEs) with probable or definite relationship to the study drug as determined by the investigator. The proportion of subjects with any TEAE was similar between the DefenCath™ arm and the control arm.

Death occurred in 5.3% of patients in the control arm vs 4.5% of patients in the DEFENCATH™ arm


1. Labriola et al. Nephrol Dial Transplant. 2008;23:1666–1672. 2. Lok CE, Mokrzycki MH. Kidney Int. 2011;79:587–598. 3. Soi et al. Int J Nephrol Renovasc Dis. 2016;9:95-103. 4. Data on file. CorMedix Inc. 5. CorMedix Inc. Press release. http://www.cormedix.com/cormedix-inc-announces-positive-results-neutrolin-phase-3-lock-100-study-based-recommendation-independent-data-safety-monitoring-board/. Accessed October 13, 2020.