The Benefit of Hemodialysis Plus Hemoperfusion on Mortality

August 24, 2022 updated by: Gengru Jiang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

1362

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Changhai Hospital
      • Shanghai, Shanghai, China, 200000
        • Longhua Hospital Shanghai University of Traditional Chinese Medicine
      • Shanghai, Shanghai, China, 200000
        • RenJi hospital
      • Shanghai, Shanghai, China, 200000
        • Ruijin Hospital
      • Shanghai, Shanghai, China, 200000
        • Shanghai 6th People's Hospital
      • Shanghai, Shanghai, China, 200000
        • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
      • Shanghai, Shanghai, China, 200000
        • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
      • Shanghai, Shanghai, China, 200000
        • Shanghai Tongji Hospital, Tongji University School of Medicine
      • Shanghai, Shanghai, China, 200000
        • Shanghai Zhongshan Hospital
      • Shanghai, Shanghai, China, 200000
        • Yangpu District Central Hospital Affiliated to Tongji University
      • Shanghai, Shanghai, China, 200092
        • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: regular hemodialysis
Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week
Device: hemodialysis
Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week
Experimental: hemoperfusion combined with hemodialysis
Combination of hemodialysis and hemoperfusion treatment at least once every two week
Device: hemodialysis
Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week
Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: From date of enrollment until the end of study, assessed up to 24 months
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)
Time Frame: From date of enrollment until the end of study, assessed up to 24 months
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
Time Frame: From date of enrollment until the end of study, assessed up to 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Changhai Hospital
Shanghai Zhongshan Hospital
RenJi Hospital
Ruijin Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai University of Traditional Chinese Medicine
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai 6th People's Hospital
Yangpu District Central Hospital Affiliated to Tongji University

Investigators

  • Study Director: Gengru Jiang, doctoral, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

July 20, 2017

First Submitted That Met QC Criteria

July 20, 2017

First Posted (Actual)

July 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 29, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-16-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The mortality data will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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