The Benefit of Hemodialysis Plus Hemoperfusion on Mortality

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1,362 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,362

Conditions

End-stage Renal Disease

Interventions

hemoperfusion combined with hemodialysisDEVICE

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)

hemodialysisDEVICE

Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Patients must meet all of the following criteria are eligible: 1. Age ≥ 18 years old 2. 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: 1. White blood cell count \< 4×10\^9/L and / or platelet count \< 100×10\^9/L 2. Cerebral hemorrhage in the past 12 weeks 3. MACEs in the past 8 weeks 4. Severe heart failure (New York Heart Association \[NYHA\] class IV) 5. Active gastrointestinal bleeding, or coagulation dysfunction 6. Malignant tumor 7. Active infection 8. Pregnancy or lactation 9) Mental disabilities

Locations (11)

Changhai Hospital

Shanghai, Shanghai Municipality, China

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

RenJi Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

All-cause mortality

Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment

Time frame: From date of enrollment until the end of study, assessed up to 24 months

Secondary Outcomes

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

Time frame: 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

Time frame: From date of enrollment until the end of study, assessed up to 24 months

Data from ClinicalTrials.gov

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