Kidney Failure,ChronicNCT02525497
Safety, Effectiveness and Manipulability Evaluation of a Domestic PD Machine
A study testing FM peritoneal dialysis machine and HOMECHOICE peritoneal dialysis machine in people with Kidney Failure,Chronic, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This study is a randomized, multi-center，crossover study of a domestic FM peritoneal dialysis machine and Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure,Chronic
- What is being tested?
- FM peritoneal dialysis machine and HOMECHOICE peritoneal dialysis machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to 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 Dialysis duration:≥30 days Sign the written informed consent
Who cannot join
- Hemodialysis Exit site infection or tunnel infection Peritonitis ≤30 days before screening Catheter mechanical failure Anti-HIV positive Allergic to components of dialysate Comorbidity:Active, residual malignant tumor, or systemic infection, liver cirrhosis, severe congestive heart failure,hypertension Poor compliance Pregnant or lactating, women of childbearing age do not agree to use effective contraceptive measures during the trial Has a history of alcoholism and drug abuse (defined as illegal drugs) Any circumstances when patients are believed unsuitable for this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multicenter, Crossover Study Comparing the Domestic FM Peritoneal Dialysis Machine With Baxter HOMECHOICE
This study is a randomized, multi-center，crossover study of a domestic FM peritoneal dialysis machine and Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine.
Read the detailed description
Our study is a randomized, multi-center，crossover study. It compares a domestic FM peritoneal dialysis machine with Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine.
- Conditions
- Kidney Failure,Chronic
- Being tested
- FM peritoneal dialysis machine, HOMECHOICE peritoneal dialysis machine
- Keywords
- Automated PD, Effectiveness, Safety, Manipulability
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FM peritoneal dialysis machineDevice
FM peritoneal dialysis machine APD 10L/10h
HOMECHOICE peritoneal dialysis machineDevice
HOMECHOICE peritoneal dialysis machine APD 10L/10h
| Study group | Role | What they receive |
|---|---|---|
| FM peritoneal dialysis machine | Experimental | FM peritoneal dialysis machine APD 10L/10h; Receives: Device: FM peritoneal dialysis machine |
| HOMECHOICE peritoneal dialysis machine | Active comparator | HOMECHOICE peritoneal dialysis machine APD 10L/10h; Receives: Device: HOMECHOICE peritoneal dialysis machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily peritoneal Kt/V
Measured: 1 day
Secondary outcomes (1)
The accuracy of filling
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure,ChronicStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiangmei, Chinese PLA General Hospital
- Investigators
- CHEN Xiangmei, yes, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525497
- Sponsor's protocol ID
- MD-PD-2014
- Status last verified
- Dec 2019
- First submitted
- 14 Aug 2015
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cao XY, He YN, Zhou JH, Sun SR, Miao LN, Chen W, Fang JA, Wang M, Wang NS, Lin HL, Liu J, Ni ZH, Liu WH, Na Y, Zhao JY, Guo ZY, Zheng HG, Shi W, Jiang GR, Cai GY, Chen XM. Safety, Effectiveness, and Manipulability of Peritoneal Dialysis Machines Made in China: A Randomized, Crossover, Multicenter Clinical Study. Chin Med J (Engl). 2018 Dec 5;131(23):2785-2791. doi: 10.4103/0366-6999.246079.
PubMed 30511680
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Crossover Study Comparing the Domestic FM Peritoneal Dialysis Machine With Baxter HOMECHOICE
- ClinicalTrials.gov ID
- NCT02525497
- Acronym / sponsor ID
- MD-PD-2014
- Conditions
- Kidney Failure,Chronic
- Keywords
- Automated PD, Effectiveness, Safety, Manipulability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Aug 2015 (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.
This study is a randomized, multi-center，crossover study of a domestic FM peritoneal dialysis machine and Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine.
Detailed description
Our study is a randomized, multi-center，crossover study. It compares a domestic FM peritoneal dialysis machine with Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FM peritoneal dialysis machine | Experimental | Device: FM peritoneal dialysis machineFM peritoneal dialysis machine APD 10L/10h; |
| HOMECHOICE peritoneal dialysis machine | Active comparator | Device: HOMECHOICE peritoneal dialysis machineHOMECHOICE peritoneal dialysis machine APD 10L/10h; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥18, male or female Dialysis duration:≥30 days Sign the written informed consent
Key exclusion criteria (1 listed)
- Hemodialysis Exit site infection or tunnel infection Peritonitis ≤30 days before screening Catheter mechanical failure Anti-HIV positive Allergic to components of dialysate Comorbidity:Active, residual malignant tumor, or systemic infection, liver cirrhosis, severe congestive heart failure,hypertension Poor compliance Pregnant or lactating, women of childbearing age do not agree to use effective contraceptive measures during the trial Has a history of alcoholism and drug abuse (defined as illegal drugs) Any circumstances when patients are believed unsuitable for this 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 |
|---|---|---|
| FM peritoneal dialysis machineFM peritoneal dialysis machine APD 10L/10h | Device | FM peritoneal dialysis machine |
| HOMECHOICE peritoneal dialysis machineHOMECHOICE peritoneal dialysis machine APD 10L/10h | Device | HOMECHOICE peritoneal dialysis machine |
Primary outcome
Daily peritoneal Kt/V
Time frame: 1 day
1 secondary outcome
The accuracy of filling
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Derived from this study: PubMed 30511680Cao XY, He YN, Zhou JH, Sun SR, Miao LN, Chen W, Fang JA, Wang M, Wang NS, Lin HL, Liu J, Ni ZH, Liu WH, Na Y, Zhao JY, Guo ZY, Zheng HG, Shi W, Jiang GR, Cai GY, Chen XM. Safety, Effectiveness, and Manipulability of Peritoneal Dialysis Machines Made in China: A Randomized, Crossover, Multicenter Clinical Study. Chin Med J (Engl). 2018 Dec 5;131(23):2785-2791. doi: 10.4103/0366-6999.246079.
- Individual participant dataSharing planned: No
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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.
CHEN Xiangmei, yes study director
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FM peritoneal dialysis machine and HOMECHOICE peritoneal dialysis machine in people with Kidney Failure,Chronic, run by Chinese PLA General Hospital at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Daily peritoneal Kt/V (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02525497, which also lists 1 linked publication.
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 11 Dec 2019.