Chronic Kidney FailureNCT03456232
High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease
A study testing High-flux hemodialysis and Hemodiafiltration in people with Chronic Kidney Failure, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This study evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on small and moderate molecule substances clearance. Meanwhile, this study evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on cardiac function. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Failure
- What is being tested?
- High-flux hemodialysis and Hemodiafiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2017to 20 Mar 2018
- 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 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has end-stage renal disease.
- Subject has been on regular dialysis treatment for at least 6 months.
- Subject has autologous vascular access.
- Subject is offered thrice weekly hemodialysis.
- Subject is offered 4 hours duration hemodialysis.
Who cannot join
- Infectious disease
- Poor echocardiographic window that was unsuitable for interpretation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510080
wei shi, MD,PhD, ＋86-20-83850849, 13925056339@163.com
Yi Li, Master, ＋86-20-81346722, 13580588265@139.com
About this study
This study evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on small and moderate molecule substances clearance. Meanwhile, this study evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on cardiac function. In this self matching study, participants will receive high-flux hemodialysis compared to hemodiafiltration.
Read the detailed description
Hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water, is one of the most commonly replacement therapy.
Hemodiafiltration is a combination of hemodialysis and hemofiltration with two modes of treatment advantages, both by diffusion and convection principle to remove harmful substances in the blood.
- Conditions
- Chronic Kidney Failure
- Being tested
- High-flux hemodialysis, Hemodiafiltration
- Keywords
- hemodialysis, hemodiafiltration, end-stage renal disease
- 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.
High-flux hemodialysisOther
High-flux hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water.
HemodiafiltrationOther
Hemodiafiltration is a combination of hemodialysis and hemofiltration with two modes of treatment advantages, both by diffusion and convection principle to remove harmful substances in the blood.
| Study group | Role | What they receive |
|---|---|---|
| High-flux hemodialysis | Experimental | High-flux hemodialysis lasting for 4 hours Receives: Other: High-flux hemodialysis |
| Hemodiafiltration | Active comparator | Hemodiafiltration lasting for 4 hours Receives: Other: Hemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of moderate molecule substance
Clearance rate of b2-microglobulin for one dialysis.
Measured: 4 hours after dialysis
Secondary outcomes (1)
Left ventricular ejection fraction
Left ventricular ejection fraction is calculated by dividing the volume of blood pumped from the left ventricle per beat, also known as stroke volume, by the end-diastolic volume.
Measured: 4 hours after dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start21 Dec 2017
- Primary completion10 Mar 2018 (estimated)
- Study completion20 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Shi, MD,PhD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456232
- Sponsor's protocol ID
- GDREC2017324H
- Status last verified
- Feb 2018
- First submitted
- 27 Feb 2018
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Supporting Information: study protocol, statistic analysis plan, informed consent form, clinical study report. Time Frame: Data will be available within 1 year of study completion. Access Criteria: Data access requests will be reviewed by an external Independent Review panel. Requestors will be required to sign a Data Access Agreement.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease
- ClinicalTrials.gov ID
- NCT03456232
- Acronym / sponsor ID
- GDREC2017324H
- Conditions
- Chronic Kidney Failure
- Keywords
- hemodialysis, hemodiafiltration, end-stage renal disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 10 Mar 2018 (estimated)
- Study completion
- 20 Mar 2018 (estimated)
- First posted
- 7 Mar 2018 (actual)
- 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 evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on small and moderate molecule substances clearance. Meanwhile, this study evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on cardiac function. In this self matching study, participants will receive high-flux hemodialysis compared to hemodiafiltration.
Detailed description
Hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water, is one of the most commonly replacement therapy.
Hemodiafiltration is a combination of hemodialysis and hemofiltration with two modes of treatment advantages, both by diffusion and convection principle to remove harmful substances in the blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-flux hemodialysis | Experimental | Other: High-flux hemodialysisHigh-flux hemodialysis lasting for 4 hours |
| Hemodiafiltration | Active comparator | Other: HemodiafiltrationHemodiafiltration lasting for 4 hours |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has end-stage renal disease.
- Subject has been on regular dialysis treatment for at least 6 months.
- Subject has autologous vascular access.
- Subject is offered thrice weekly hemodialysis.
- Subject is offered 4 hours duration hemodialysis.
Key exclusion criteria (2 listed)
- Infectious disease
- Poor echocardiographic window that was unsuitable for interpretation
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 |
|---|---|---|
| High-flux hemodialysisHigh-flux hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water. | Other | High-flux hemodialysis |
| HemodiafiltrationHemodiafiltration is a combination of hemodialysis and hemofiltration with two modes of treatment advantages, both by diffusion and convection principle to remove harmful substances in the blood. | Other | Hemodiafiltration |
Primary outcome
Clearance of moderate molecule substance
Time frame: 4 hours after dialysis
Clearance rate of b2-microglobulin for one dialysis.
1 secondary outcome
Left ventricular ejection fraction
Time frame: 4 hours after dialysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Individual participant dataSharing planned: Undecided. Supporting Information: study protocol, statistic analysis plan, informed consent form, clinical study report. Time Frame: Data will be available within 1 year of study completion. Access Criteria: Data access requests will be reviewed by an external Independent Review panel. Requestors will be required to sign a Data Access Agreement.
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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.
Wei Shi, MD,PhD principal investigator
Guangdong Provincial People's 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 High-flux hemodialysis and Hemodiafiltration in people with Chronic Kidney Failure, run by Guangdong Provincial People's 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Li, Master (＋86-20-81346722, 13580588265@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance of moderate molecule substance (time frame: 4 hours after dialysis). 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 7 Mar 2018.