A Multi-center, Open-label, Randomized Trial of Hemodialysis Plus Hemoperfusion on Blood β2-microglobulin (β2-MG), Parathyroid Hormone (PTH) and C Reactive Protein (CRP) Clearance in Maintenance Hemodialysis Patients
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
• Blood β2-MG \> 30 mg/L and/or 300 pg/ml \< immunoreactive parathyroid hormone (iPTH) \< 800 pg/ml and/or CRP ≥ 16.2 pg/ml
• Kt/V ≥ 1.2 eight weeks prior to enrollment
• Signed informed consent form
Locations
Other Locations
China
Changhai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Zhiyong Guo, professor
drguozhiyong@163.com
18368328998
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 410
Treatments
Active_comparator: regular hemodialysis
Routine blood purification therapy (including hemodialysis, hemofiltration) 3 times a week
Experimental: hemoperfusion combined with hemodialysis
Routine blood purification therapy 3 times a week + Combination of hemodialysis and hemoperfusion treatment once a week
Related Therapeutic Areas
Sponsors
Leads: Changhai Hospital