End Stage Renal DiseaseNCT01862679
Randomised Study of High-flux Haemodialysis and Haemodiafiltration
A study testing High-flux haemodialysis and Haemodiafiltration in people with End Stage Renal Disease, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
The most common forms of renal replacement therapy currently in use are high flux haemodialysis (HF-HD) and haemodiafiltration (HDF). Although these techniques appear similar to the patient, there are important differences in what happens to the blood as it travels through the dialysis machine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- High-flux haemodialysis and Haemodiafiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2013to Mar 2014
- 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
- Receiving HF-HD for at least 3 months
- Reliable vascular access (i.e. use of the same fistula, graft or tunnelled central venous catheter for at least 1 month)
- Aged 18 or older
Who cannot join
- Currently receiving HDF
- Emergency hospital admissions within the preceding 4 weeks
- Life expectancy less than 6 months
- Neoplasia
- Unable to give informed consent
- Unable to perform QoL questionnaire or self report recovery post-dialysis time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Blind, Prospective, Randomised Comparative Study of High-flux Haemodialysis and Haemodiafiltration
The most common forms of renal replacement therapy currently in use are high flux haemodialysis (HF-HD) and haemodiafiltration (HDF). Although these techniques appear similar to the patient, there are important differences in what happens to the blood as it travels through the dialysis machine.
During HDF, the machine controls hydrostatic pressure across the dialyser to remove additional water together with toxins from the blood and this fluid volume is continually replaced with an ultra-pure solution. HDF has a theoretical advantage removing more waste substances, especially larger molecules, from the blood than HF-HD which may be of benefit to the patient in the medium to long term.Despite the theoretical advantages, trials have so far been unable to find any significant difference in death rates or the development of health problems among patients on HDF or HF-HD.
Read more
It is therefore important to examine other factors which may help doctors and patients to decide which treatment to use. The investigators have designed a study which aims to answer three main questions:
- Does HDF make patients feel better?
- Is blood pressure more stable on HDF in comparison with HF-HD?
- Are Phosphate levels and other blood parameters better controlled with HDF than HF-HD?
The investigators will do this by randomly assigning patients on HF-HD to receive 2 months of either HF-HD or HDF with as equivalent treatment prescriptions as possible and without the patient knowing which treatment they are receiving. After two months the patients will switch to the alternative form of dialysis for a further two months. During the study the investigators will ask the patients how long it took them to recover from the preceding session of dialysis, assess the frequency of symptomatic low blood pressure and also perform blood tests at set intervals to measure specific blood parameters.
- Conditions
- End Stage Renal Disease
- Being tested
- High-flux haemodialysis, Haemodiafiltration
- 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 haemodialysisOther
High-flux haemodialysis is the standard dialysis modality currently in use in the UK
HaemodiafiltrationProcedure or surgery
During Haemodiafiltration, the dialysis machine removes more water from the blood than during "normal" hemodialysis. The additional liquid is continually replaced with an ultra-pure solution. Thus, the machine exchanges a high volume of fluid during treatment and removes the liquid together with toxins from the blood.
| Study group | Role | What they receive |
|---|---|---|
| 8 weeks HF haemodialysis / 8 weeks HD-filtration | Experimental | 8 weeks high-flux haemodialysis followed by 8 weeks haemodiafiltration Receives: Other: High-flux haemodialysis; Procedure: Haemodiafiltration |
| 8 weeks HD-filtration /8 weeks HF haemodialysis | Experimental | 8 weeks haemodiafiltration followed by 8 weeks high-flux haemodialysis Receives: Other: High-flux haemodialysis; Procedure: Haemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the average time taken to fully recover post dialysis
Self-assessment by patient of hours/mins to full recovery after dialysis
Measured: Baseline compared 8 week treatment point
Secondary outcomes (10)
Number of symptomatic hypotension events
Measured: Number of events noted by nurse at each dialysis session in each of the two arms of the study. Each arm= 3 sessions per week for 8 weeks
Number of dialysis circuit clotting events
Measured: Number of events noted by nurse at each dialysis session in each of the two arms of the study. Each arm= 3 sessions per week for 8 weeks
Pre-dialysis serum concentrations of potassium
Measured: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of phosphate
Measured: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of vitamin B12.
Measured: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of PTH.
Measured: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of beta-2-microglobulin
Measured: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of betaine
Measured: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of interleukin-6
Measured: Measured at baseline, and after 4 and 8 weeks of each treatment period
Kt/V urea.
Measured: : Measured at baseline, and after 4 and 8 weeks of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert MacTier, Md, FRCP, Study director, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862679
- Sponsor's protocol ID
- GN12RE153
- Status last verified
- Jun 2016
- First submitted
- 22 Apr 2013
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Blind, Prospective, Randomised Comparative Study of High-flux Haemodialysis and Haemodiafiltration
- ClinicalTrials.gov ID
- NCT01862679
- Acronym / sponsor ID
- GN12RE153
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 May 2013 (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.
The most common forms of renal replacement therapy currently in use are high flux haemodialysis (HF-HD) and haemodiafiltration (HDF). Although these techniques appear similar to the patient, there are important differences in what happens to the blood as it travels through the dialysis machine.
During HDF, the machine controls hydrostatic pressure across the dialyser to remove additional water together with toxins from the blood and this fluid volume is continually replaced with an ultra-pure solution. HDF has a theoretical advantage removing more waste substances, especially larger molecules, from the blood than HF-HD which may be of benefit to the patient in the medium to long term.Despite the theoretical advantages, trials have so far been unable to find any significant difference in death rates or the development of health problems among patients on HDF or HF-HD.
It is therefore important to examine other factors which may help doctors and patients to decide which treatment to use. The investigators have designed a study which aims to answer three main questions:
- Does HDF make patients feel better?
- Is blood pressure more stable on HDF in comparison with HF-HD?
- Are Phosphate levels and other blood parameters better controlled with HDF than HF-HD?
The investigators will do this by randomly assigning patients on HF-HD to receive 2 months of either HF-HD or HDF with as equivalent treatment prescriptions as possible and without the patient knowing which treatment they are receiving. After two months the patients will switch to the alternative form of dialysis for a further two months. During the study the investigators will ask the patients how long it took them to recover from the preceding session of dialysis, assess the frequency of symptomatic low blood pressure and also perform blood tests at set intervals to measure specific blood parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8 weeks HF haemodialysis / 8 weeks HD-filtration | Experimental | Other: High-flux haemodialysis, Procedure: Haemodiafiltration8 weeks high-flux haemodialysis followed by 8 weeks haemodiafiltration |
| 8 weeks HD-filtration /8 weeks HF haemodialysis | Experimental | Other: High-flux haemodialysis, Procedure: Haemodiafiltration8 weeks haemodiafiltration followed by 8 weeks high-flux haemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Receiving HF-HD for at least 3 months
- Reliable vascular access (i.e. use of the same fistula, graft or tunnelled central venous catheter for at least 1 month)
- Aged 18 or older
Key exclusion criteria (6 listed)
- Currently receiving HDF
- Emergency hospital admissions within the preceding 4 weeks
- Life expectancy less than 6 months
- Neoplasia
- Unable to give informed consent
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 haemodialysisHigh-flux haemodialysis is the standard dialysis modality currently in use in the UK | Other | 8 weeks HD-filtration /8 weeks HF haemodialysis, 8 weeks HF haemodialysis / 8 weeks HD-filtration |
| HaemodiafiltrationDuring Haemodiafiltration, the dialysis machine removes more water from the blood than during "normal" hemodialysis. The additional liquid is continually replaced with an ultra-pure solution. Thus, the machine exchanges a high volume of fluid during treatment and removes the liquid together with toxins from the blood. | Procedure or surgery | 8 weeks HD-filtration /8 weeks HF haemodialysis, 8 weeks HF haemodialysis / 8 weeks HD-filtration |
Primary outcome
Change in the average time taken to fully recover post dialysis
Time frame: Baseline compared 8 week treatment point
Self-assessment by patient of hours/mins to full recovery after dialysis
10 secondary outcomes
Number of symptomatic hypotension events
Time frame: Number of events noted by nurse at each dialysis session in each of the two arms of the study. Each arm= 3 sessions per week for 8 weeks
Number of dialysis circuit clotting events
Time frame: Number of events noted by nurse at each dialysis session in each of the two arms of the study. Each arm= 3 sessions per week for 8 weeks
Pre-dialysis serum concentrations of potassium
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of phosphate
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of vitamin B12.
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of PTH.
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of beta-2-microglobulin
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of betaine
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of interleukin-6
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Kt/V urea.
Time frame: : Measured at baseline, and after 4 and 8 weeks of each treatment period
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 7 Jun 2016.
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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.
Robert MacTier, Md, FRCP study director
NHS Greater Glasgow and Clyde
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 haemodialysis and Haemodiafiltration in people with End Stage Renal Disease, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 3 inclusion and 6 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 7 Jun 2016. 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 United Kingdom. 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?
Change in the average time taken to fully recover post dialysis (time frame: Baseline compared 8 week treatment point). 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 Jun 2016.