Exploratory Study to Explore the Safety and Efficacy of the HDx Therapy Using Theranova 500 Dialyzer in Comparison to Hemodiafiltration

Exclusion Criteria

• •No informed consent provided
• •Significant psychiatric disorder, mental disability, or other condition that may interfere with the patient's ability to provide informed consent
• •Pregnant, breastfeeding, or planning to become pregnant
• •Unstable vascular access associated with risk of low and variable extracorporeal blood flow rate (QB)
• •Chronic liver disease, known paraprotein-associated disease, known bleeding disorders (e.g., gastrointestinal bleed, colonic polyps, small bowel angiodysplasia and active peptic ulcers)
• •Major bleeding episode (i.e. soft tissue bleeding, blood in stool, joint damage, retinal bleeding, extensive mucosal bleeding, exsanguination, cerebral hemorrhage) ≤ 12 weeks prior to enrollment
• •Blood (red blood cell) transfusion ≤ 12 weeks prior to enrollment
• •Clinical signs of acute infection ≤ 4 weeks prior to enrollment
• •Active cancer, except for basal cell or squamous cell skin cancer
• •Positive serology test for human immunodeficiency virus or hepatitis infection
• •Scheduled for planned interventions requiring hospitalization \> 1 week
• •Scheduled for living-donor transplantation within the study period
• •Currently participating in another interventional clinical study or has participated in another interventional clinical study in the past 3 months that may interfere with this study