The Benefit of Hemodialysis Plus Hemoperfusion on Mortality

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2021-12-31

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.

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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).

Conditions

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End-stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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regular hemodialysis

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

Group Type ACTIVE_COMPARATOR

hemodialysis

Intervention Type DEVICE

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

hemoperfusion combined with hemodialysis

Combination of hemodialysis and hemoperfusion treatment at least once every two week

Group Type EXPERIMENTAL

hemoperfusion combined with hemodialysis

Intervention Type DEVICE

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)

hemodialysis

Intervention Type DEVICE

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

Interventions

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hemoperfusion combined with hemodialysis

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)

Intervention Type DEVICE

hemodialysis

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Gengru Jiang

Director of Renal Division, Department of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gengru Jiang, doctoral

Role: STUDY_DIRECTOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

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