Theranova Randomized, Controlled, Trial (RCT) in China

Inclusion Criteria:

1. Patients aged ≥18 years old and ≤80 years old, regardless of gender;

2. Patients who are able to sign informed consent form (ICF) after an explanation ofthe proposed study;

3. Patients who receive in-center HD treatment at a site that routinely implements highflux dialysis and HDF;

4. Patients who have been stable receiving in-center HD/HDF for >3 months prior tostudy enrollment;

5. Patients with kidney failure receiving maintained HD treatment with a history ofthrice weekly HD, and at least 1 HDF session within 1 month prior to the study shallbe judged by the investigator;

6. Patients who have an adequate arteriovenous (AV) fistula or graft, or dual-lumentunneled catheter capable of providing a blood flow rate (QB) of at least 250mL/min;

7. Patients have no changes in dialysis prescription (dialyzer, time, dialysis fluidflow rate (QD), QB, sufficient dialysis anticoagulation, and stable prescribeddoses) over last 6 treatments as judged by the investigator. The dialysis treatmenttime should be 3.5 to 4.5 hours per session with minimum QB of 250 mL/min and QD of 500 mL/min;

8. Patients with a minimum total convective volume (including ultrafiltration (UF)) of 16 L post-dilution for the most recent HDF treatment;

9. Patients who have Kt/Vurea > 1.2 for the last 2 measurements, with the most recentKt/Vurea measurement taken within 4 weeks before or during study screening.

Exclusion Criteria:

1. Patients who have acute kidney injury with the chance for recovery;

2. Pregnant and lactating women;

3. Patients diagnosed with a New York Heart Association (NYHA) Class IV congestiveheart failure, or acute coronary syndrome, and/or who have suffered a myocardialinfarction within 3 months prior to the start of the study;

4. Patients with known hemodynamic instability, anemia (hemoglobin <90 g/L), and/orpatients with hemoglobin >130g/L for coagulation risk;

5. Patients with active or ongoing infection as per investigator's judgement (e.gC-reactive protein [CRP] level more than 5 folds of normal);

6. Patients who are severely malnourished or with significant disease that interfereswith liver synthetic function ( e.g. with serum albumin <30 g/L);

7. Patients with positive serology tests for Hepatitis B surface antigen, Hepatitis Ctotal antibody, and advanced liver, or pulmonary disease as judged by theinvestigator;

8. Patients with positive serology tests for human immunodeficiency virus (HIV),Syphilis;

9. Patients receiving immunosuppressive treatment or with autoimmune disease;

10. Patients with a history of solid tumors requiring anti-cancer therapy in the past ornext 6 months, or with a life expectancy of <1 year, or patients with history ofhematology neoplasm;

11. Patients who are pre-scheduled for a living donor kidney transplant within the next 1 year, who plan a change to peritoneal dialysis (PD) within the next 1 year, or whorequire single-needle dialysis therapy;

12. Patients who have had an allergic response to polyarylethersulfone (PAES) orpolysulfone (PS) membrane or have history of poor tolerance to dialyzers withsynthetic membranes;

13. Patients with a history of severe mental disorders who are unable to provide consentor comply with study procedures as assessed by the investigator;

14. Patients who are currently participating in or have previously participated in otherinterventional clinical studies during the past 30 days;

15. Patients with any comorbidity possibly conflicting with the study as judged by theinvestigator.