Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study

Evaluation of Domestic Hemodialysis Machine (WEGO DBB-27C) : A Multi-center Clinical Study

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02904343

Enrollment

Registered

2016-09-16

Start date

2017-09-30

Completion date

2017-12-31

Last updated

2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis

Keywords

hemodialysis machine, quality, safety, domestic

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.

Interventions

DEVICEdomestic hemodialysis machine

WEGO, DBB-27C

DEVICEimported hemodialysis machine

Fresenius, 4008s

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age≥18, male or female 2. Maintenance hemodialysis duration\>3 months 3. Regular hemodialysis,3 times a week,4 hours per session 4. Sign the written informed consent

Exclusion criteria

1. Acute kidney injury 2. Prepare to transfer to kidney transplantation or peritoneal dialysis in a year. 3. Positive in Hepatitis B virus, hepatitis C virus, syphilis or HIV 4. Pregnancy or lactation 5. Under other drug trial 6. Acute infection, severe heart, lung, liver, nervous diseases, malignant tumor 7. Can not be treated in accordance with the research program

Design outcomes

Primary

Measure	Time frame
Adverse reactions associated with the use of dialysis machines	0 to 3 months

Secondary

Measure	Time frame	Description
The results of endotoxin level of dialysate	0,1,2,3 months	endotoxin level of dialysis fluid at outlet
The results of bacterial culture of dialysate	0,1,2,3 months	bacterial culture of dialysis fluid at outlet
Clearance rate of uremic toxins	0,1,2,3 months	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026