An estimated thirty million people in the U.S. are affected by chronic kidney disease. That translates into one out of three adults who are at risk. The majority, however, are not even aware that they have the disease.
According to an article released this year by the National Kidney Foundation, some of the risks associated with kidney disease are diabetes, high blood pressure, obesity, and heart disease. Infections follow the disease itself as the cause of death in hemodialysis patients.
A study of a large representation of dialysis patients in the US, that is listed in Pub Med Central as PMCID: PMC3532948, concluded that catheter use is prevalent in hemodialysis care as compared to other modes of access.
Central venous catheters used in hemodialysis are associated not only with mechanical complications but also with high rates of bloodstream infections. These infections add about six billion dollars to an already overburdened healthcare system. The infections occur despite the extreme preventative measures used in catheter care and hand hygiene.
Catheters deliver treatment to a patient by gaining access to the patient’s bloodstream. They can be used in outpatient settings at home or in the hospital. Since they have direct access to a patient’s bloodstream, they are often the source of infections acquired during a hospital stay.
Neutrolin is an investigational catheter lock solution that was recently granted Fast Track Designation by the FDA. Researchers announced that in cases of end-stage renal disease, Neutrolin reduced bloodstream infections in patients using a central venous catheter by seventy-one percent. The solution, administered through a catheter, is both antifungal and antibacterial.
CorMedix Inc., the company that developed Neutrolin, is currently working with the FDA in an effort to gain commercial distribution approval in the United States.
About the LOCK-IT-100 Study
Results of the Phase III LOCK-IT-100 Study show that Neutrolin reduces infections that are catheter-related. The study involved a final total of 806 participants across seventy locations in the United States. Data was gathered from approximately 136,000 days of catheter use.
Adverse events were somewhat lower in the Neutrolin arm than in the control arm. The CEO of CorMedix Inc. will be sharing more information in the next few months as data from the study is released. Details of the study are available here.
CorMedix is the biopharmaceutical developer of Neutrolin. The company’s focus is on the development of products designed to treat and prevent infectious disease.
The company’s lead product is Neutrolin, a solution that is designed to prevent bloodstream infections resulting from the use of central venous catheters.
Neutrolin is an antimicrobial solution that is currently in Phase III development to treat chronic hemodialysis patients.
The FDA has granted Neutrolin Fast Track designation. The FDA also designated Neutrolin as a Qualified Infectious Disease Product. The designation brings with it a potential review of a future marketing application.