Image

Multi-center Clinical Study on Hemoperfusion of KHA80

Multi-center Clinical Study on Hemoperfusion of KHA80

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

To evaluate the decreasing rate of blood IL-6, β2-MG and PTH in maintenance hemodialysis patients in the 52nd week compared with routine hemodialysis.

Description

394 patients with maintenance hemodialysis were included in the study, and the blood purification time was ≥8 hours per week (including routine hemodialysis, high-throughput hemodialysis, hemodialysis filtration, hemoperfusion, etc.). Randomly assign the control group (197 cases) to receive hemodialysis or hemodialysis filtration treatment, and the frequency of treatment is ≥2 times/week; The experimental group (197 cases) were randomly assigned to receive Jianfan KHA80 hemoperfusion treatment on the basis of hemodialysis or hemodiafiltration treatment, and the frequency of hemoperfusion treatment was ≥2 times/month. The follow-up data of 0, 4, 12, 24, 36 and 52 weeks of treatment in the two groups were collected, and the information of combined medication and adverse events was also collected.

Eligibility

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.

Study details
    Uremia
    Uremic Osteodystrophy
    Dialysis Related Complication

NCT06233838

First Affiliated Hospital of Fujian Medical University

15 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.