Status:
COMPLETED
Theranova Randomized, Controlled, Trial (RCT) in China
Lead Sponsor:
Vantive Health LLC
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Chronic Kidney Failure
Acute Kidney Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Traditional hemodialysis (HD) therapy is very effective in clearing urea and smaller middle molecules, but is limited in clearing larger middle molecules. These accumulated large middle-molecular-weig...
Eligibility Criteria
Inclusion
- Patients aged ≥18 years old and ≤80 years old, regardless of gender;
- Patients who are able to sign informed consent form (ICF) after an explanation of the proposed study;
- Patients who receive in-center HD treatment at a site that routinely implements high flux dialysis and HDF;
- Patients who have been stable receiving in-center HD/HDF for \>3 months prior to study enrollment;
- 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;
- 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;
- 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;
- Patients with a minimum total convective volume (including ultrafiltration (UF)) of 16 L post-dilution for the most recent HDF treatment;
- 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
- Patients who have acute kidney injury with the chance for recovery;
- Pregnant and lactating women;
- 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;
- Patients with known hemodynamic instability, anemia (hemoglobin \<90 g/L), and/or patients with hemoglobin \>130g/L for coagulation risk;
- Patients with active or ongoing infection as per investigator's judgement (e.g C-reactive protein \[CRP\] level more than 5 folds of normal);
- Patients who are severely malnourished or with significant disease that interferes with liver synthetic function ( e.g. with serum albumin \<30 g/L);
- 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;
- Patients with positive serology tests for human immunodeficiency virus (HIV), Syphilis;
- Patients receiving immunosuppressive treatment or with autoimmune disease;
- 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;
- 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;
- 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;
- Patients with a history of severe mental disorders who are unable to provide consent or comply with study procedures as assessed by the investigator;
- Patients who are currently participating in or have previously participated in other interventional clinical studies during the past 30 days;
- Patients with any comorbidity possibly conflicting with the study as judged by the investigator.
Key Trial Info
Start Date :
June 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2023
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT05309291
Start Date
June 22 2022
End Date
July 6 2023
Last Update
July 14 2025
Active Locations (10)
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1
Investigational Site
Beijing, China, 100013
2
Investigational Site
Beijing, China, 100034
3
Investigational Site
Dalian, China, 116001
4
Investigational Site
Dalian, China, 116011