Effects of Hemodialysis Plus Hemoperfusion in Maintenance Hemodialysis Patients: A Clinical Study (NCT05639010) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of Hemodialysis Plus Hemoperfusion in Maintenance Hemodialysis Patients: A Clinical Study
China410 participantsStarted 2023-01-01
Plain-language summary
This multi-center, open-label, randomized, parallel controlled trial aims to investigate the efficacy of hemoperfusion (HP) in combination with hemodialysis (HD) by assessing blood β2-microglobulin (β2-MG), parathyroid hormone (PTH) and C reactive protein (CRP) clearance in maintenance hemodialysis patients.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18-80 years, regardless of gender
. Stable maintenance hemodialysis for ≥ 3 months with relatively fixed dialysis pattern
. Hemodialysis treatment 3 times per week, total treatment duration ≥ 10 hours per week, vascular access unlimited
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in blood β2-microglobulin (β2-MG) values
Timeframe: From date of enrollment until the end of study, assessed up to 52 weeks
2
Changes in blood Parathyroid Hormone (PTH) values
Timeframe: From date of enrollment until the end of study, assessed up to 52 weeks
3
Changes in blood C Reactive Protein (CRP) values
Timeframe: From date of enrollment until the end of study, assessed up to 52 weeks
. Known allergic reaction, contraindication or intolerance to the material of the dialyzer or perfusion apparatus
. 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
. Blood flow \<200 ml/min
. Regular hemoperfusion treatment for more than 3 months and at least once every 2 weeks
. Active bleeding or chronic gastrointestinal bleeding, or other severe bleeding tendencies or coagulation disorders
. History of unstable angina pectoris, myocardial infarction, severe arrhythmia, pericarditis, myocarditis, cardiac surgery or peripheral vascular surgery in the last 8 weeks
. Cerebral hemorrhage in the last 12 weeks
. Severe heart failure (New York Heart Association class IV)