Comparison of the Clinical Performance of 3 THERANOVA 400 Dialyzer Prototypes With a High-Flux Dialyzer in Hemodialysis Mode

Inclusion criteria

• Patient has end-stage renal disease
• Patient is 18 years of age or older
• Patient is male or female
• Patient, if female, is non-pregnant; and if capable of becoming pregnant, will be using a medically acceptable means of contraception during participation in the study (Note: Female capable of becoming pregnant [defined as a woman less than 55 years old who has not had partial or full hysterectomy or oophorectomy] must have a negative serum beta human chorionic gonadotropin [β-hCG] test within 2 weeks of first study treatment)
• Patient has been receiving HD or HDF therapy (HDF patients are allowed if their treatments during the study can be safely and effectively performed with HD) for ≥3 months prior to study enrollment and is expected to survive for at least 12 months after enrollment
• Patient has a stable functioning native fistula, Gore-Tex graft, or double-lumen central venous catheter capable of providing a blood flow rate of ≥280 mL/min (with an acceptable recirculation rate, such that solute removal is not likely to be affected) based on the judgment of the treating physician
• Patient is in clinically stable condition as judged by the treating physician and as demonstrated by stable medical history for 30 days prior to enrollment, physical examination, and laboratory testing
• Patient is willing to comply with the study requirements for therapy during the entire study treatment period
• Patient is capable of providing written informed consent to participate in the study

Exclusion criteria

• Patient is undergoing single-needle dialysis
• Patient has an abnormal κ/λ ratio (less than 0.37, or greater than 3.1)
• Patient has a known active infection and is currently receiving antibiotic treatment
• Patient has known active cancer
• Patient has a known positive serology test for human immunodeficiency virus (HIV) or hepatitis B, C or E
• Patient has a known serious hemostasis disorder
• Patient has a known monoclonal gammopathy (eg, monoclonal gammopathy of uncertain significance, smouldering [asymptomatic] multiple myeloma, symptomatic multiple myeloma, nonsecretory multiple myeloma, plasmacytomas, or plasma cell leukemia)
• Patient has a known polyclonal gammopathy (eg, connective tissue disease, liver disease, chronic infection, lymphoproliferative disorder, or other hematologic condition)
• Patient has any other known comorbidity that could, in the opinion of the Investigator, potentially conflict with the study purpose or procedures (eg, severe hypoalbuminemia or anemia)
• Patient has a known significant psychiatric disorder or mental disability that could interfere with the patient's ability to provide informed consent and/or comply with protocol procedures
• Patient has a history of non-compliance with the dialysis prescription, as assessed by the Investigator
• Patient has participated in another interventional clinical study in the past 3 months, or is currently participating in another interventional clinical study