HemodialysisNCT02904343
Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study
A study testing domestic hemodialysis machine and imported hemodialysis machine in people with Hemodialysis, run by Chinese PLA General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- domestic hemodialysis machine and imported hemodialysis machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Evaluation of Domestic Hemodialysis Machine (WEGO DBB-27C) : A Multi-center Clinical Study
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.
- Conditions
- Hemodialysis
- Being tested
- domestic hemodialysis machine, imported hemodialysis machine
- Keywords
- hemodialysis machine, quality, safety, domestic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
domestic hemodialysis machineDevice
WEGO, DBB-27C
imported hemodialysis machineDevice
Fresenius, 4008s
| Study group | Role | What they receive |
|---|---|---|
| Group of domestic hemodialysis machine | Experimental | Not described Receives: Device: domestic hemodialysis machine |
| Group of imported hemodialysis machine | Active comparator | Not described Receives: Device: imported hemodialysis machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse reactions associated with the use of dialysis machines
Measured: 0 to 3 months
Secondary outcomes (3)
The results of endotoxin level of dialysate
endotoxin level of dialysis fluid at outlet
Measured: 0,1,2,3 months
The results of bacterial culture of dialysate
bacterial culture of dialysis fluid at outlet
Measured: 0,1,2,3 months
Clearance rate of uremic toxins
Measured: 0,1,2,3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startSep 2017 (estimated)
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: The sponsors want to stop the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangmei Chen, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904343
- Sponsor's protocol ID
- S2015-046-01
- Status last verified
- Jun 2018
- First submitted
- 22 Aug 2016
- Last updated
- 26 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Domestic Hemodialysis Machine (WEGO DBB-27C) : A Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT02904343
- Acronym / sponsor ID
- S2015-046-01
- Conditions
- Hemodialysis
- Keywords
- hemodialysis machine, quality, safety, domestic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsors want to stop the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of domestic hemodialysis machine | Experimental | Device: domestic hemodialysis machine |
| Group of imported hemodialysis machine | Active comparator | Device: imported hemodialysis machine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| domestic hemodialysis machineWEGO, DBB-27C | Device | Group of domestic hemodialysis machine |
| imported hemodialysis machineFresenius, 4008s | Device | Group of imported hemodialysis machine |
Primary outcome
Adverse reactions associated with the use of dialysis machines
Time frame: 0 to 3 months
3 secondary outcomes
The results of endotoxin level of dialysate
Time frame: 0,1,2,3 months
The results of bacterial culture of dialysate
Time frame: 0,1,2,3 months
Clearance rate of uremic toxins
Time frame: 0,1,2,3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing domestic hemodialysis machine and imported hemodialysis machine in people with Hemodialysis, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse reactions associated with the use of dialysis machines (time frame: 0 to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.