Theranova Randomized, Controlled, Trial (RCT) in China

This is an interventional treatment trial for Chronic Kidney Failure Read More

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 of the proposed study;
3. Patients who receive in-center HD treatment at a site that routinely implements high flux dialysis and HDF;
4. Patients who have been stable receiving in-center HD/HDF for >3 months prior to study enrollment;
5. Patients with kidney failure receiving maintained HD treatment with a history of thrice weekly HD, and at least 1 HDF session within 1 month prior to the study shall be judged by the investigator;
6. Patients who have an adequate arteriovenous (AV) fistula or graft, or dual-lumen tunneled catheter capable of providing a blood flow rate (QB) of at least 250 mL/min;
7. Patients have no changes in dialysis prescription (dialyzer, time, dialysis fluid flow rate (QD), QB, sufficient dialysis anticoagulation, and stable prescribed doses) over last 6 treatments as judged by the investigator. The dialysis treatment time 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 recent Kt/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 congestive heart failure, or acute coronary syndrome, and/or who have suffered a myocardial infarction within 3 months prior to the start of the study;
4. Patients with known hemodynamic instability, anemia (hemoglobin <90 g/L), and/or patients with hemoglobin >130g/L for coagulation risk;
5. Patients with active or ongoing infection as per investigator's judgement (e.g C-reactive protein [CRP] level more than 5 folds of normal);
6. Patients who are severely malnourished or with significant disease that interferes with liver synthetic function ( e.g. with serum albumin <30 g/L);
7. Patients with positive serology tests for Hepatitis B surface antigen, Hepatitis C total antibody, and advanced liver, or pulmonary disease as judged by the investigator;
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 or next 6 months, or with a life expectancy of <1 year, or patients with history of hematology 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 who require single-needle dialysis therapy;
12. Patients who have had an allergic response to polyarylethersulfone (PAES) or polysulfone (PS) membrane or have history of poor tolerance to dialyzers with synthetic membranes;
13. Patients with a history of severe mental disorders who are unable to provide consent or comply with study procedures as assessed by the investigator;
14. Patients who are currently participating in or have previously participated in other interventional clinical studies during the past 30 days;
15. Patients with any comorbidity possibly conflicting with the study as judged by the investigator.