Trials / Recruiting
RecruitingNCT06233838
Multi-center Clinical Study on Hemoperfusion of KHA80
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 394 (estimated)
- Sponsor
- First Affiliated Hospital of Fujian Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-01-13
- Primary completion
- 2026-02-28
- Completion
- 2027-05-31
- First posted
- 2024-01-31
- Last updated
- 2025-01-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06233838. Inclusion in this directory is not an endorsement.