Multi-center Clinical Study on Hemoperfusion of KHA80

January 10, 2025 updated by: wanjianxin, First Affiliated Hospital of Fujian Medical University

Prospective, Multicenter, Randomized, Open Label Study on the Efficacy and Safety of Comparison of KHA80 Blood Perfusion Combined With Hemodialysis and Conventional Hemodialysis in Clearing IL-6, β2-MG and PTH in Maintenance Hemodialysis Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

394

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KHA80 hemoperfusion treatment
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.
Device: KHA80 hemoperfusion treatment
On the basis of hemodialysis or hemodiafiltration treatment, Jianfan KHA80 hemoperfusion treatment was given, and the frequency of hemoperfusion treatment was ≥2 times/month.
No Intervention: Routine hemodialysis
Randomly assign the control group (197 cases) to receive hemodialysis or hemodialysis filtration treatment, and the frequency of treatment is ≥2 times/week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of change of IL-6, β2-MG and PTH
Time Frame: in the 52nd week
the rate of change of IL-6, β2-MG and PTH in the 52nd week of maintenance hemodialysis patients compared with routine hemodialysis.
in the 52nd week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Fujian Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 13, 2025

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8339-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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