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Completed

NCT Number: NCT02461953

Combination of Hemodialysis With Hemoperfusion：A Clinical Study

This study is a prospective, randomized, controlled multicenter clinical study. The aim of the study is to investigate whether the combination of maintenance hemodialysis (MHD) with hemoperfusion (HP) could improve the clearance rate of middle and large molecule uremic toxins so as to improve the quality of life of MHD patients and reduce their mortality rate.

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Key information

Conditions

Renal Dialysis Hemoperfusion Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age≥18, male or female
  • Maintenance hemodialysis duration>3 months
  • Regular hemodialysis,3 times a week,4 hours per session
  • Vascular access unlimited
  • iPTH≥300pg/ml
  • Sign the written informed consent

Exclusion criteria

  • Allergic to dialysis equipment
  • PLT<60×10^9/L
  • Blood flow<200ml/min
  • Serum albumin<30g/L
  • Kt/V<1.2
  • iPTH>800pg/ml
  • Hemodiafiltration
  • Coagulation disorder, severe bleeding tendency, with active bleeding
  • Severe hypotension, severe cardiopulmonary insufficiency
  • Under other drug trial
  • Acute infection, severe heart, lung, liver, nervous diseases, malignant tumor

Treatment and study plan

hemoperfusion apparatus

Device

Other names: hemoperfusion apparatus(HA-130;Jafron Biomedical Co., Ltd）

low flux dialyzer

Device

high flux dialyzer

Device

Primary outcomes

  1. Clearance rate of uremic toxins

    Time frame: 0,3,6,12 months

Secondary outcomes

  1. Evaluation of quality of life

    Time frame: 0,3,6,12 months

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

HA130 Hemoperfusion Apparatus Combined Hemodialysis to Improve Quality of Life in Patients Undergoing Maintenance Hemodialysis：A Perspective, Randomized, Controlled Multicenter Clinical Study

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 3, 2015
Registry last updated
Jun 26, 2018

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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