Study to Compare Safety and Tolerability of AKST1210 Column at 2 Blood Flow Rates in Subjects With ESRD on Hemodialysis

Exclusion criteria

• . Patients for whom adequate anticoagulation cannot be achieved, such as those with severe anemia, severe hemorrhagic diathesis, severe gastrointestinal ulcers, or who are receiving anticoagulant medications for any reason other than as required for HD. Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is allowed.
• . Patients for whom extracorporeal circulation therapy is contraindicated, such as those with severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute seizure disorder, or severe uncontrolled hypertension.
• . Patients with Kt/V \< 1.2 during recent 8-week period prior to run-in.
• . History of hypersensitivity to heparin, including heparin-induced thrombocytopenia.
• . History of hypersensitivity to the AKST1210 column or its components.
• . Patients who are not anticipated to be able to tolerate blood-flow rates of 450 mL/min during HD (e.g., new vascular access that cannot be used with 14G or 15G needles).
• . Patients who are at higher risk for intradialytic hypotension (IDH) including:
• . Medical records indicating the occurrence IDH (SBP \< 90 mmHg) in more than 30% of HD sessions during a recent 8-week period prior to run-in;