Hemodialysis-Associated AmyloidosisHD-1NCT04160351
A Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser Among Patients With Chronic Haemodialysis
A study testing Theranova 400 and Elisio-19H in people with Hemodialysis-Associated Amyloidosis and Dialysis Amyloidosis, run by Selayang Hospital at 1 site in Malaysia.
Trial summary
This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis-Associated Amyloidosis, Dialysis Amyloidosis, Quality of Life
- What is being tested?
- Theranova 400 and Elisio-19H
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2019to 31 Dec 2021
- 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
- 18 years of age or above
- End stage kidney failure receiving hemodialysis for at least 3 years
- Currently receiving hemodialysis at our center regularly
- Written informed consent
Who cannot join
- Patients with hemodiafiltration
- Catheter-related blood stream infection in the preceding 4 weeks
- Malfunctioning of HD catheter
- Planned transfer to peritoneal dialysis or transplant within 90 days
- Pregnancy
- History of active alcohol or substance abuse in the previous 6 months
- Concurrent participation in another interventional study
- Other medical condition which, in the investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser In Removing Beta-2- Microglobulin Among Patients With End-Stage Kidney Disease On Chronic Haemodialysis
This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.
Read the detailed description
This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off(MCO) Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.
Patients who are initially on High Flux Dialyser will be randomised into either MCO Dialyser (modality A) or High Flux Dialyser (modality B) dialysate. The dialysate flow (QD) and blood flow (QB) remains unchanged throughout study period. After 12 treatments (4 weeks) a 4-weeks wash-out phase using High-flux dialyzers was performed to minimize carry-over-effects. After the 4-weeks washout phase, the modality is switched to the alternative one for 8 weeks.
- Being tested
- Theranova 400, Elisio-19H
- Keywords
- Hemodialysis-Associated Amyloidosis, Dialysis Amyloidosis, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theranova 400Device
medium cut-off dialyser
Elisio-19HDevice
high flux dialyser
| Study group | Role | What they receive |
|---|---|---|
| MCO Dialyser | Experimental | 12 treatments (4 weeks) with Medium Cut-Off Dialyzer Receives: Device: Theranova 400 |
| High Flux Dialyser | Active comparator | 12 treatments (4 weeks) with High Flux Dialyzer Receives: Device: Elisio-19H |
What is being measured
The primary outcome is the main question the study is designed to answer.
Removal of Beta-2-microglobulin
Changes to Beta-2-microglobulin level
Measured: 4 weeks
Changes to Quality of Life
Changes to Quality of life Using SF-36
Measured: 27 weeks
Secondary outcomes (2)
Inflammatory state after intervention
Changes to C-Reactive Protein Level
Measured: 4 weeks
Changes to Quality of Life
Changes to Quality of life Using EQ-5D-5L
Measured: 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Dec 2019
- Primary completion1 Jun 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis-Associated AmyloidosisStudies 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
- Model description
- This is an open label, cross-over group, single-centre randomised controlled trial comparing MCO Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selayang Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hin Seng Wong, MD, Study director, Ministry of Health, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160351
- Sponsor's protocol ID
- HS/CTP/HD/001
- Acronym
- HD-1
- Status last verified
- May 2022
- First submitted
- 5 Nov 2019
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-Label, Cross Over Group, Single-Centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-Off Membrane Dialyser Compared With High Flux Dialyser In Removing Beta-2- Microglobulin Among Patients With End-Stage Kidney Disease On Chronic Haemodialysis
- ClinicalTrials.gov ID
- NCT04160351
- Acronym / sponsor ID
- HD-1 / HS/CTP/HD/001
- Keywords
- Hemodialysis-Associated Amyloidosis, Dialysis Amyloidosis, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Selayang HospitalOther government
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Nov 2019 (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 is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.
Detailed description
This is an open label, cross-over group, single-centre randomised controlled trial comparing Medium Cut Off(MCO) Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.
Patients who are initially on High Flux Dialyser will be randomised into either MCO Dialyser (modality A) or High Flux Dialyser (modality B) dialysate. The dialysate flow (QD) and blood flow (QB) remains unchanged throughout study period. After 12 treatments (4 weeks) a 4-weeks wash-out phase using High-flux dialyzers was performed to minimize carry-over-effects. After the 4-weeks washout phase, the modality is switched to the alternative one for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open label, cross-over group, single-centre randomised controlled trial comparing MCO Dialyser with High Flux Dialyser in patients with end-stage renal disease on chronic haemodialysis.
| Arm | Type | Receives |
|---|---|---|
| MCO Dialyser | Experimental | Device: Theranova 40012 treatments (4 weeks) with Medium Cut-Off Dialyzer |
| High Flux Dialyser | Active comparator | Device: Elisio-19H12 treatments (4 weeks) with High Flux Dialyzer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or above
- End stage kidney failure receiving hemodialysis for at least 3 years
- Currently receiving hemodialysis at our center regularly
- Written informed consent
Key exclusion criteria (8 listed)
- Patients with hemodiafiltration
- Catheter-related blood stream infection in the preceding 4 weeks
- Malfunctioning of HD catheter
- Planned transfer to peritoneal dialysis or transplant within 90 days
- Pregnancy
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 |
|---|---|---|
| Theranova 400medium cut-off dialyser | Device | MCO Dialyser |
| Elisio-19Hhigh flux dialyser | Device | High Flux Dialyser |
Primary outcome
Removal of Beta-2-microglobulin
Time frame: 4 weeks
Changes to Beta-2-microglobulin level
Changes to Quality of Life
Time frame: 27 weeks
Changes to Quality of life Using SF-36
2 secondary outcomes
Inflammatory state after intervention
Time frame: 4 weeks
Changes to Quality of Life
Time frame: 27 weeks
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 19 May 2022.
- Individual participant dataSharing planned: No
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.
Hin Seng Wong, MD study director
Ministry of Health, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theranova 400 and Elisio-19H in people with Hemodialysis-Associated Amyloidosis and Dialysis Amyloidosis, run by Selayang Hospital at 1 site in Malaysia.
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 8 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 19 May 2022. 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 Malaysia. 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?
Removal of Beta-2-microglobulin (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 19 May 2022.