Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients

Inclusion criteria

• ESRD patients age 22 and older, or between ages 18 and 21 with a weight ≥ 40kg.
• Clinically stable as judged by the treating physician and as demonstrated by stable medical history for 30 days prior to enrollment, physical examination, and laboratory testing.
• Hemodialysis therapy with high-flux dialyzers for at least 3 months immediately prior to study enrollment and expected to survive for the next 12 months.
• Expected to maintain an acceptable urea clearance (Kt/V) with a dialyzer of an approximate surface area of 1.7 m2.
• Currently being dialyzed at an in-center setting, on a schedule of 3 times per week.
• Able to give informed consent after an explanation of the proposed study, and who are willing to comply with the study requirements for therapy during the entire study treatment period.
• Have a stable functioning vascular access (arteriovenous fistula, graft, or dual lumen tunneled catheter); stable access will be confirmed by observed Kt/V >= 1.2 for past 2 measurements, and/or achievement of within 15% the prescribed blood flow rate over 3 treatments prior to study entry.

Exclusion criteria

• Are female and pregnant, lactating, or planning to become pregnant during the study period. Note: Female subjects of childbearing potential, defined as a woman <55 years old who has not had a partial or full hysterectomy or oophorectomy, must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test at screening. Subjects of childbearing potential must use a medically acceptable means of contraception during their participation in the study.
• Have chronic liver disease.
• Have a known paraprotein-associated disease.
• Have known bleeding disorders (e.g., gastrointestinal bleed, colonic polyps, small bowel angiodysplasia, and active peptic ulcers).
• Have had a major bleeding episode (i.e. soft tissue bleeding, blood in stool, prolonged nose bleeds, joint damage, retinal bleeding, extensive mucosal bleeding, exsanguination, cerebral hemorrhage) ≤ 12 weeks prior to randomization.
• Have had a blood (red blood cell) transfusion ≤ 12 weeks prior to randomization.
• Have had an acute infection ≤ 4 weeks prior to randomization.
• Have active cancer, except for basal cell or squamous cell skin cancer.
• Have a known serum κ/λ FLC ratio that is less than 0.37, or greater than 3.1.b
• Have a known monoclonal gammopathy (monoclonal gammopathy of uncertain significance, smoldering [asymptomatic] multiple myeloma, symptomatic multiple myeloma, plasmacytomas, or plasma cell leukemia).
• Have a known polyclonal gammopathy (connective tissue disease, liver disease, chronic infection, lymphoproliferative disorder, or other hematologic condition).
• Have a positive serology test for human immunodeficiency virus or hepatitis infection.
• Have a significant psychiatric disorder or mental disability.
• Are scheduled for planned interventions requiring hospitalization > 1 week.
• Are scheduled for living-donor transplantation within the study period + 3 months, plan to change to PD therapy within the next 9 months, plan to change to a home hemodialysis treatment, or plan to relocate to an area where no study center is located.
• Are currently participating in another interventional clinical study or has participated in another interventional clinical study in the past 3 months.
• Have a history of non-compliance with HD as assessed by an investigator.
• Have had a major cardiovascular or cerebrovascular event within 3 months of study entry.
• Have a history with consistent evidence of intradialytic hypotension.
• Have uncontrolled (systolic BP > 180 mmHg) hypertension.
• Have had adverse reactions to dialyzer materials.