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NCT Number: NCT03227770

The Benefit of Hemodialysis Plus Hemoperfusion on Mortality

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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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital, Shanghai, Shanghai Municipality, China

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

hemoperfusion combined with hemodialysis

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

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 24, 2017
Registry last updated
Aug 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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