Enroll in a Study

End-Stage Renal Disease & Dialysis

CSL Behring
Protocol # CSL300_2301

Study Details

1-5 years

Patient Information

Are you 18 years of age or older with ESRD receiving hemodialysis via an arteriovenous graft? This study aims to evaluate the effectiveness and safety of CSL300 (Clazakizumab), a potential new treatment, specifically for people like yourself who are living with End-Stage Kidney Disease (ESKD) and undergoing dialysis.

Your involvement can help us evaluate the effectiveness and safety of CSL300 (Clazakizumab), potentially leading to improved treatment options for patients worldwide.

Throughout the study, you will receive high-quality medical care from our dedicated research team. This includes regular health assessments, monitoring, and support, ensuring that your well-being is closely observed and managed.

Our research team is available to answer any questions you may have and provide further details about the study. Participation is voluntary, and deciding not to participate will not affect your current or future medical care in any way. All information collected during the study will be kept confidential.

Physician Information

Target population: Adult male and female subjects 18 years of age with End-Stage Kidney Disease (ESKD) & undergoing dialysis treatments.

The problem: High risk of cardiovascular complications in individuals with End-Stage Kidney Disease (ESKD).

Why the problem exists: Patients with ESKD are at significantly higher risk for cardiovascular diseases, such as heart attacks, strokes, and heart failure. This is because kidney dysfunction and dialysis can both contribute to factors like inflammation, fluid imbalances, and altered vascular function, which in turn affect the cardiovascular system.

New approach to solve the problem: The goal is to evaluate the effectiveness and safety of CSL300 (Clazakizumab) in reducing inflammation and improving cardiovascular outcomes in this vulnerable group of patients. Given the elevated cardiovascular risks faced by individuals with ESKD, this population is specifically chosen to test how CSL300 may help improve outcomes in both kidney disease management and related heart conditions.

Study: A Single arm sTudy to evaluate the effectiveness of EndoAVF in a Pre-dialysis population (STEP study)

Study duration: 1-5 years

New intervention: Clazakizumab is an experimental monoclonal antibody that targets interleukin-6 (IL-6), a protein involved in the inflammatory process.