Benefits of Hemodialysis Plus Hemoperfusion: A Clinical Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Device: regular hemodialysis
* Device: hemoperfusion combined with hemodialysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: regular hemodialysis<br>Routine blood purification therapy (including hemodialysis, hemofiltration) 3 times a week | Device: regular hemodialysis<br>* Routine blood purification therapy (including hemodialysis, hemofiltration) 3 times a week<br>|
| Experimental: hemoperfusion combined with hemodialysis<br>Routine blood purification therapy 3 times a week + Combination of hemodialysis and hemoperfusion treatment once a week | Device: regular hemodialysis<br>* Routine blood purification therapy (including hemodialysis, hemofiltration) 3 times a week<br>Device: hemoperfusion combined with hemodialysis<br>* Hemoperfusion combined with hemodialysis treatment will perform once a week. The hemoperfusion apparatus will use type KHA80 hemoperfusion apparatus (Zhuhai Jafron Biomedical Co., Ltd, China)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood β2-microglobulin (β2-MG) values | Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood β2-MG in maintenance hemodialysis patients | From date of enrollment until the end of study, assessed up to 52 weeks | 
| Changes in blood Parathyroid Hormone (PTH) values | Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood PTH in maintenance hemodialysis patients | From date of enrollment until the end of study, assessed up to 52 weeks | 
| Changes in blood C Reactive Protein (CRP) values | Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood CRP in maintenance hemodialysis patients | From date of enrollment until the end of study, assessed up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum protein-bound toxin (e.g., p-Cresol sulfate, indophenol sulphate) values | Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of serum protein-bound toxin (e.g., p-Cresol sulfate, indophenol sulphate) in maintenance hemodialysis patients | From date of enrollment until the end of study, assessed up to 52 weeks | 
| Improvement in patients' quality of life | Assessment of quality of life using the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire | From date of enrollment until the end of study, assessed up to 52 weeks | 
| Improvement in patients' sleep disturbance | Assessment of sleep disturbance using the Pittsburgh Sleep Quality Index (PSQI) | From date of enrollment until the end of study, assessed up to 52 weeks | 
| Improvement in patients' pruritus | Assessment of pruritus using the Duo's pruritus score | From date of enrollment until the end of study, assessed up to 52 weeks |