Dialysis upgrade: can adding a filter remove more toxins?
NCT ID NCT05639010
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding a special filter (hemoperfusion) to regular dialysis can better remove waste products like beta-2 microglobulin, parathyroid hormone, and C-reactive protein from the blood. About 410 adults with end-stage kidney disease on maintenance dialysis will be randomly assigned to standard dialysis or dialysis plus the extra filter once a week. The goal is to see if the combination improves toxin clearance, which could help manage the disease better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hemoperfusion device (KHA80) combined with hemodialysis
- What this could lead to
- If it works, this could lead to a better way to remove harmful substances from the blood in people on dialysis, potentially improving their health and quality of life.
- What could go wrong
- This is a mid-stage trial testing a device, not a new drug. The benefits may be modest, and the results might not apply to all dialysis patients. Risks include possible side effects from the added procedure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
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
-
About 410 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 to 80 years
- Sex
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Anyone
- Healthy volunteers
-
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: 1. Age 18-80 years, regardless of gender 2. Stable maintenance hemodialysis for ≥ 3 months with relatively fixed dialysis pattern 3. Hemodialysis treatment 3 times per week, total treatment duration ≥ 10 hours per week, vascular access unlimited 4. Blood β2-MG \> 30 mg/L and/or 300 pg/ml \< immunoreactive parathyroid hormone (iPTH) \< 800 pg/ml and/or CRP ≥ 16.2 pg/ml 5. Kt/V ≥ 1.2 eight weeks prior to enrollment 6. Signed informed consent form Exclusion Criteria: 1. Known allergic reaction, contraindication or intolerance to the material of the dialyzer or perfusion apparatus 2. Test indicators meeting one or more of the following: white blood cell \<4 x 10\^9/L, platelet count \<60 x 10\^9/L, serum albumin \<30 g/L 3. Blood flow \<200 ml/min 4. Regular hemoperfusion treatment for more than 3 months and at least once every 2 weeks 5. Active bleeding or chronic gastrointestinal bleeding, or other severe bleeding tendencies or coagulation disorders 6. History of unstable angina pectoris, myocardial infarction, severe arrhythmia, pericarditis, myocarditis, cardiac surgery or peripheral vascular surgery in the last 8 weeks 7. Cerebral hemorrhage in the last 12 weeks 8. Severe heart failure (New York Heart Association class IV) 9. Acute infection, acute or critical illnesses such as severe cardiac, pulmonary, hepatic or neurological disease and malignancy 10. Pregnancy or breastfeeding 11. Participation in a clinical trial or ongoing clinical trial within 3 months 12. Expected survival of less than 1 year 13. Not considered suitable for participation in this trial 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
-
Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
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Other studies related to the condition(s) this trial covers.
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