NCT02904343

Brief Summary

An important reason for the costs of hemodialysis treatment in China are expensive is the hemodialysis machine and related products mainly rely on imports. Hemodialysis machine is the basis equipment of the hemodialysis treatment. After years of research and development, China has had the domestic hemodialysis machine. However, due to the lack of control studies of domestic and imported hemodialysis machine, thus causing the domestic hemodialysis machine promotion has been hindered. The aim of this study is to verify the quality and safety of domestic hemodialysis machine.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

1 month

First QC Date

August 22, 2016

Last Update Submit

June 22, 2018

Conditions

Hemodialysis

Keywords

hemodialysis machinequalitysafetydomestic

Outcome Measures

Primary Outcomes (1)

  • Adverse reactions associated with the use of dialysis machines

    0 to 3 months

Secondary Outcomes (3)

  • The results of endotoxin level of dialysate

    0,1,2,3 months

  • The results of bacterial culture of dialysate

    0,1,2,3 months

  • Clearance rate of uremic toxins

    0,1,2,3 months

Study Arms (2)

Group of domestic hemodialysis machine

EXPERIMENTAL
Device: domestic hemodialysis machine

Group of imported hemodialysis machine

ACTIVE COMPARATOR
Device: imported hemodialysis machine

Interventions

domestic hemodialysis machineDEVICE

WEGO, DBB-27C

Group of domestic hemodialysis machine
imported hemodialysis machineDEVICE

Fresenius, 4008s

Group of imported hemodialysis machine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age≥18, male or female
  • Maintenance hemodialysis duration\>3 months
  • Regular hemodialysis,3 times a week,4 hours per session
  • Sign the written informed consent

You may not qualify if:

  • Acute kidney injury
  • Prepare to transfer to kidney transplantation or peritoneal dialysis in a year.
  • Positive in Hepatitis B virus, hepatitis C virus, syphilis or HIV
  • Pregnancy or lactation
  • Under other drug trial
  • Acute infection, severe heart, lung, liver, nervous diseases, malignant tumor
  • Can not be treated in accordance with the research program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor,Chief physician,Academician of Chinese Academy of Engineering

Study Record Dates

First Submitted

August 22, 2016

First Posted

September 16, 2016

Study Start

September 1, 2017

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

June 26, 2018

Record last verified: 2018-06