Effects of Hemodialysis Plus Hemoperfusion in Maintenance Hemodialysis Patients: A Clinical Study

In this HD/HP vs HD trial, the investigators plan to enroll 410 maintenance hemodialysis patients. Twelve medical centers in the Shanghai metropolitan area have expressed interest in participating. Participants will be randomized into 2 groups after a 1-month washout period. The control group (205 patients) will be treated with hemodialysis or hemofiltration with a frequency of 3 times/week; the experimental group (205 patients) will be treated with Jafron KHA80 hemoperfusion apparatus in addition to hemodialysis or hemofiltration with a frequency of 1 time/week. Follow-up data before the last dialysis at 4, 12, 24, 36 and 52 weeks of treatment were collected from both groups, including the following: routine physical examination, laboratory tests (blood routine, blood biochemistry, β2-MG, PTH, CRP, liver/kidney function, coagulation system tests, etc.), chest X-ray, electrocardiogram and cardiac ultrasound. Dialysis adequacy as defined by standard Kt/V will be calculated. Comorbidities, combined medications and adverse events will also be captured. The primary outcomes will include change in blood β2-MG, PTH and CRP values. Secondary outcomes will include change values for serum protein-bound toxins (e.g., p-Cresol sulfate, indophenol sulphate), improvement in patient quality of life (Kidney Disease Quality of Life Short Form), sleep disturbance (Pittsburgh Sleep Quality Index) and pruritus (Duo's pruritus score).

Inclusion criteria

• 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

Exclusion criteria

• Known allergic reaction, contraindication or intolerance to the material of the dialyzer or perfusion apparatus
• Test indicators meeting one or more of the following: white blood cell <4 x 10^9/L, platelet count <60 x 10^9/L, serum albumin <30 g/L
• Blood flow <200 ml/min
• Regular hemoperfusion treatment for more than 3 months and at least once every 2 weeks
• Active bleeding or chronic gastrointestinal bleeding, or other severe bleeding tendencies or coagulation disorders
• History of unstable angina pectoris, myocardial infarction, severe arrhythmia, pericarditis, myocarditis, cardiac surgery or peripheral vascular surgery in the last 8 weeks
• Cerebral hemorrhage in the last 12 weeks
• Severe heart failure (New York Heart Association class IV)
• Acute infection, acute or critical illnesses such as severe cardiac, pulmonary, hepatic or neurological disease and malignancy
• Pregnancy or breastfeeding
• Participation in a clinical trial or ongoing clinical trial within 3 months
• Expected survival of less than 1 year
• Not considered suitable for participation in this trial by the investigator