Completed

ROCKetTheranova 400 Dialyzer vs. HDF in Kidney Failure Patients on Hemodialysis

Study Aim

This study aims to compare the effectiveness of the Theranova 400 Dialyzer versus HDF in reducing Beta-2 Microglobulin and Lambda Free Light Chains levels in patients with kidney failure who are on hemodialysis.

What is being tested

Theranova 400 Dialyzer

+ FX 800 Dialyzer

Device

Who is being recruted

Urogenital Diseases+11

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 80 Years

+24 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: June 2022

See protocol details

Summary

Principal SponsorVantive Health LLC

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 22, 2022

Actual date on which the first participant was enrolled.

This study focuses on kidney failure patients who are undergoing hemodialysis. The main goal is to compare the effectiveness of a new type of dialyzer, Theranova 400, with the current hemodiafiltration (HDF) treatment. The study aims to improve the clearance of larger toxins that traditional hemodialysis cannot effectively remove. These toxins may lead to inflammation, atherosclerosis, and calcification, which can indirectly cause patient death. Theranova 400, with its innovative Medium Cut-Off® membranes, promises better clearance of these toxins while retaining essential proteins, offering a potential improvement in care for kidney failure patients on hemodialysis. During the study, participants will undergo dialysis sessions using either the Theranova 400 dialyzer or the current HDF treatment. The effectiveness of each treatment will be measured by the reduction ratio of specific toxins, Beta-2 Microglobulin (β2-MG) and Lambda Free Light Chains (λ FLC), in the blood before and after the dialysis session. The reduction ratio is calculated by subtracting the post-dialysis toxin level from the pre-dialysis level, then dividing by the pre-dialysis level. This study hopes to demonstrate that the Theranova 400 dialyzer is not inferior to the current HDF treatment in terms of toxin clearance.

Official TitleA Randomized, Open-label, Controlled, Parallel, Multicenter Study in Kidney Failure Patients on Hemodialysis Comparing the Theranova Dialyzer to Hemodiafiltration

NCT05309291

Principal SponsorVantive Health LLC

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

323 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney Failure, ChronicPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesAcute Kidney Injury

Criteria

9 inclusion criteria required to participate

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;

Show More Criteria

15 exclusion criteria prevent from participating

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;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

1 week, 1 session in mid-week HD therapy. Pre dialysis blood samples taken from fistula needle or central venous catheter. Post dialysis blood samples taken from arterial sampling port of bloodline

Group II

Active Comparator

1 week, 1 session in mid-week HDF therapy. Pre dialysis blood samples taken from fistula needle or central venous catheter. Post dialysis blood samples taken from arterial sampling port of bloodline

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Suspended

Investigational Site

Beijing, ChinaOpen Investigational Site in Google Maps

Suspended

Investigational Site

Beijing, China

Suspended

Investigational Site

Dalian, China

Suspended

Investigational Site

Dalian, China

Completed10 Study Centers