Renal DialysisNCT02461953
Combination of Hemodialysis With Hemoperfusion：A Clinical Study
A study testing hemoperfusion apparatus, low flux dialyzer and high flux dialyzer in people with Renal Dialysis and Hemoperfusion, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Dialysis, Hemoperfusion, Quality of Life
- What is being tested?
- hemoperfusion apparatus, low flux dialyzer and high flux dialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- Jun 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
- 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
Who cannot join
- Allergic to dialysis equipment
- PLT<60×10^9/L
- Blood flow<200ml/min
- Serum albumin<30g/L
- Kt/V<1.2
- iPTH>800pg/ml
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HA130 Hemoperfusion Apparatus Combined Hemodialysis to Improve Quality of Life in Patients Undergoing Maintenance Hemodialysis：A Perspective, Randomized, Controlled Multicenter 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.
- Conditions
- Renal Dialysis, Hemoperfusion, Quality of Life
- Being tested
- hemoperfusion apparatus, low flux dialyzer, high flux dialyzer
- Keywords
- hemodialysis, hemoperfusion, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemoperfusion apparatusDevice
Also called hemoperfusion apparatus(HA-130;Jafron Biomedical Co., Ltd）
low flux dialyzerDevice
high flux dialyzerDevice
| Study group | Role | What they receive |
|---|---|---|
| low flux hemodialysis | Experimental | low flux hemodialysis alone, 3 times a week, 4 hours per session Receives: Device: low flux dialyzer |
| high flux hemodialysis | Experimental | high flux hemodialysis alone, 3 times a week, 4 hours per session Receives: Device: high flux dialyzer |
| low flux hemodialysis + hemoperfusion | Experimental | low flux hemodialysis 2times a week and the HD+HP once a week Receives: Device: hemoperfusion apparatus; Device: low flux dialyzer |
| high flux hemodialysis + hemoperfusion | Experimental | high flux hemodialysis 2times a week and the HD+HP once a week Receives: Device: hemoperfusion apparatus; Device: high flux dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance rate of uremic toxins
Measured: 0,3,6,12 months
Secondary outcomes (1)
Evaluation of quality of life
Measured: 0,3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startJun 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.
- Other trials for Renal DialysisStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 440 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
- NCT02461953
- Sponsor's protocol ID
- 2014-011
- Status last verified
- Jun 2018
- First submitted
- 2 Jun 2015
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
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
- HA130 Hemoperfusion Apparatus Combined Hemodialysis to Improve Quality of Life in Patients Undergoing Maintenance Hemodialysis：A Perspective, Randomized, Controlled Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT02461953
- Acronym / sponsor ID
- 2014-011
- Conditions
- Renal Dialysis, Hemoperfusion, Quality of Life
- Keywords
- hemodialysis, hemoperfusion, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Jun 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low flux hemodialysis | Experimental | Device: low flux dialyzerlow flux hemodialysis alone, 3 times a week, 4 hours per session |
| high flux hemodialysis | Experimental | Device: high flux dialyzerhigh flux hemodialysis alone, 3 times a week, 4 hours per session |
| low flux hemodialysis + hemoperfusion | Experimental | Device: hemoperfusion apparatus, Device: low flux dialyzerlow flux hemodialysis 2times a week and the HD+HP once a week |
| high flux hemodialysis + hemoperfusion | Experimental | Device: hemoperfusion apparatus, Device: high flux dialyzerhigh flux hemodialysis 2times a week and the HD+HP once a week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Allergic to dialysis equipment
- PLT<60×10^9/L
- Blood flow<200ml/min
- Serum albumin<30g/L
- Kt/V<1.2
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 |
|---|---|---|
| hemoperfusion apparatusAlso: hemoperfusion apparatus(HA-130;Jafron Biomedical Co., Ltd） | Device | high flux hemodialysis + hemoperfusion, low flux hemodialysis + hemoperfusion |
| low flux dialyzer | Device | low flux hemodialysis, low flux hemodialysis + hemoperfusion |
| high flux dialyzer | Device | high flux hemodialysis, high flux hemodialysis + hemoperfusion |
Primary outcome
Clearance rate of uremic toxins
Time frame: 0,3,6,12 months
1 secondary outcome
Evaluation of quality of life
Time frame: 0,3,6,12 months
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 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hemoperfusion apparatus, low flux dialyzer and high flux dialyzer in people with Renal Dialysis and Hemoperfusion, 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 6 inclusion and 11 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 26 Jun 2018. 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?
Clearance rate of uremic toxins (time frame: 0,3,6,12 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.