New dialysis filter shows promise in small kidney study
NCT ID NCT04395131
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new dialysis filter (Clearum HS) in 20 adults with end-stage kidney disease who were already on dialysis. The goal was to see if the new filter safely removes waste products like urea as well as or better than standard filters. Participants used their usual filter for 2 weeks, then switched to the Clearum filter for 6 weeks. The study focused on safety and how well the filter cleans the blood.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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20 people
The number who actually took part.
- Started
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Apr 2020
- Finished
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Aug 2020
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * ESRD Patients aged 18 years or older * Patients able to give informed consent (IC) and interested to participate in the study * Stable (according to the investigator) on hemodialysis for more than 3 months with previous treatments of 3x weekly hemodialysis or hemodiafiltration * Stable hemoglobin between 10 and 12 g/dl in the most recent two consecutive blood draws * Stable anticoagulation and ESA regimen with no dosing modifications in the past 1 month * Patients who have an adequate AVF or graft, capable of providing a blood flow rate of at least 300 mL/min according to sessions conducted in past month Exclusion Criteria: * Patients who have acute renal failure with the chance for recovery. * Patients who are pre-scheduled for a living kidney transplant within the next two months, who plan a change to PD within the next two months or who require single needle dialysis therapy. * Pregnant and lactating women. * Patients with a history of positive serology tests for Hepatitis B surface antigen, positive Hepatitis C total antibody, HIV and syphilis. * Patients with known hemodynamic instability, anemia (Hgb \< 90 g/L), and/or severe bleeding risks secondary to coagulation disorders. * Patients with active or ongoing infection per investigator's judgement. * Patients with a history of solid tumors requiring anti-cancer therapy in the past or next 6 months or a life expectancy less than 1 year or patients with a history of a hematology neoplasm. * Patients diagnosed with a NYHA Class IV congestive heart failure, or acute coronary syndrome and/or who have suffered a myocardial infarction within three months prior to the start of the study. * Patients with a history of severe mental disorders. * Patients who are currently participating or have previously participated in another interventional clinical trial in the past 4 weeks. * Patients who have had an allergic response to polyarylethersulfone (PAES) or polysulfone membranes or have a history of poor tolerance to dialyzers with synthetic membranes. * Patients with advanced liver, heart or pulmonary disease as judged by the Investigator * Patients with any comorbidity possibly conflicting with the study purpose or procedures as judged by the Investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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DaVita Clinical Research Germany
Düsseldorf, D-40201, Germany
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