Evaluation of KHA80 hemoperfusion in hemodialysis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effectiveness of KHA80 hemoperfusion treatment in reducing blood levels of IL-6, β2-MG, and PTH in patients undergoing maintenance hemodialysis. A total of 394 patients will be randomly assigned to either a control group receiving standard hemodialysis or an experimental group receiving KHA80 hemoperfusion in addition to their regular treatment. The study will monitor patients over 52 weeks, collecting data on treatment outcomes and any adverse events. The goal is to determine if KHA80 can provide additional benefits compared to routine hemodialysis alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years old, regardless of sex;
2. According to the 2012 KDIGO guidelines, it was diagnosed as CKD5 (EGFR ≦ 15ml/(min ˙ 1.73m2));
3. receive regular hemodialysis (including hemodialysis filtration) for 4 hours twice a week for ≧3 months;
4. blood β 2-mg ≥ 30 mg/L and/or PTH ≥ 600 pg/mL and/or IL-6 ≥ 16.2 pg/mL;
5. Sign the informed consent form.

Exclusion Criteria:

1. Those who are known to have allergic reactions, contraindications or intolerance to the materials of dialyzers and hemoperfutors;
2. Patients with severe bleeding tendency and active bleeding, or with definite coagulation dysfunction, with a platelet count of \< 60× 109/L;
3. Hemodialysis blood flow \< 200 ml/min.
4. Kt/V\<1.2；
5. Serum albumin \< 30g/L;
6. Parathyroid resection within one year;
7. people with low blood pressure and severe cardiopulmonary insufficiency;
8. lactating or pregnant women or those who plan to be pregnant within one year;
9. infection, history of malignant tumor, active stage of rheumatic immune disease;
10. Patients whose life expectancy is less than one year;
11. Other clinical researchers are currently or recently (within 30 days);
12. According to the researcher's judgment, the patient has other unsuitable conditions.

Where it's running

• The First Affiliated Hospital of Fujian Medical University
  Fuzhou, Fujian, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.