The Benefit of Hemodialysis Plus Hemoperfusion on Mortality

Study Overview
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Brief Summary
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This multi-center, open-label, randomized controlled trial aims to investigate the efficacy of hemoperfusion (HP) combined with hemodialysis (HD) by evaluating all-cause mortality and cardiovascular mortality in maintenance hemodialysis patients.

Detailed Description
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In this HD/HPvsHD trial, we plan to enroll 1364 maintenance hemodialysis patients. Eleven medical centers in Shanghai Metropolitan area have explicitly expressed interest to participate. Participants will be randomized to receive hemodialysis plus hemoperfusion or hemodialysis alone at a 1:1 ratio after 1-month run-in period. In both arms, patients will receive lBlood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment at least 10 hours per week. In the experiment group, in addition to the treatments in the control arm, hemoperfusion will be conducted at least once every two weeks using a HA130 resin hemoperfusion apparatus containing 130ml resin. Follow-up is scheduled at 3, 6, 12, 18, 24 and up to 48 months after randomization, and will consist the following: routine physical examinations, standard lab panels (blood routine, liver/kidney functions, tests of the coagulation system, etc.), chest X-ray, electrocardiogram, echocardiography, heart function rating (based on New York Heart Association grading). Dialysis adequacy defined by standard Kt/V will be calculated. Adverse events will be assessed according to the international conference on harmonization guidelines. The primary outcomes will include 24-month all-cause mortality. Secondary outcomes will include cardiovascular-related mortality, the occurrence of major cardiovascular events and the quality of life (Kidney Disease Quality of Life Short Form).

Official Title
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A Randomized, Open-label, Multi-centre Trial Comparing Hemodialysis Plus Hemoperfusion Versus Hemodialysis Alone in Adult Patients With End-stage Renal Disease (HD/HPvsHD)

Conditions
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End-stage Renal Disease

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


Participation Criteria
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Eligibility Criteria
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Patients must meet all of the following criteria are eligible: Age ≥ 18 years old Regular blood purification treatment at least 3 months before enrolled in this study 3) Standard Kt/V ≥ 1.2 Subjects with one of more of the following conditions will be excluded: White blood cell count < 4×10^9/L and / or platelet count < 100×10^9/L Cerebral hemorrhage in the past 12 weeks MACEs in the past 8 weeks Severe heart failure (New York Heart Association [NYHA] class IV) Active gastrointestinal bleeding, or coagulation dysfunction Malignant tumor Active infection Pregnancy or lactation 9) Mental disabilities

Ages Eligible for Study
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Minimum Age: 18 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>Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week | Device: hemodialysis<br>* Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week<br>|
| Experimental: hemoperfusion combined with hemodialysis<br>Combination of hemodialysis and hemoperfusion treatment at least once every two week | Device: hemoperfusion combined with hemodialysis<br>* Hemoperfusion combined with hemodialysis treatment will perform at least once every two week. The hemoperfusion apparatus will use type HA130 resin hemoperfusion apparatus (Zhuhai Jafron Biomedical Co., Ltd, China)<br>Device: hemodialysis<br>* Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment | From date of enrollment until the end of study, assessed up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular-related mortality and major cardiovascular events (MACEs) | Major cardiovascular events events including angina pectoris, acute myocardial infarction, severe arrhythmia, congestive heart failure, myocarditis, pericarditis, cardiac surgery or peripheral vascular surgery, stroke and peripheral vascular disease | From date of enrollment until the end of study, assessed up to 24 months | 
| Evaluation of quality of life | Assessment of quality of life using the KDQOL-SF (Kidney Disease Quality of Life Short Form) questionnaire | From date of enrollment until the end of study, assessed up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemoperfusion, Hemodialysis, Mortality