End Stage Renal Disease (ESRD)ASISTNCT02795286
Automated Setting of Individualized Sodium Technology
A study testing Artis Haemodialysis Machine w/ ASIST Software - Isonatremic, Artis Haemodialysis Machine w/ ASIST Software - Isotonic and Artis Haemodialysis Machine w/o ASIST Software in people with End Stage Renal Disease (ESRD), run by Vantive Health LLC at 1 site in Sweden.
Trial summary
The ASIST study is a medical device study testing the safety and efficacy of a new hemodialysis machine software in chronic haemodialysis patients. The software's intention is to reduce hemodialysis related symptoms such as unwell being, blood pressure changes by adapting the dialysis fluid ion concentration to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease (ESRD)
- What is being tested?
- Artis Haemodialysis Machine w/ ASIST Software - Isonatremic, Artis Haemodialysis Machine w/ ASIST Software - Isotonic and Artis Haemodialysis Machine w/o ASIST Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2016to Nov 2016
- 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
- Subject must be in clinically stable condition as judged by the treating physician, and demonstrated by stable medical history, physical examination, and laboratory testing for 30 days prior to enrollment.
- Subject must be receiving HD or hemodiafiltration (HDF) for at least 30 days prior to study enrollment, be dialyzing a minimum of 3 times per week in an in-center setting and each treatment session must be between 3.5 and 5 hours in duration.
- Subject has a stable functioning vascular access (arteriovenous [AV] fistula, graft, or dual-lumen tunneled catheter) based on the judgment of the treating physician and is performing dual-needle therapy with an actual blood flow rate of 250 - 400 mL/min.
- Subject has a pre-dialysis plasma sodium of ≥132 mmol/L for at least 60 days prior to study enrollment.
- Subject has achieved a dialysis dose of stdKt/Vurea ≥ 2.1 within 60 days prior to enrollment.
- Subject has a pre-dialysis hemoglobin ≥ 90 g/L measured at Screening.
Who cannot join
- Female subjects who are pregnant, lactating, or planning to become pregnant during the study period.
- Subjects who have a significant psychiatric disorder or mental disability that could interfere with the subject's ability to provide Informed Consent and/or comply with protocol procedures.
- Subjects with a medical condition that the investigator thinks may interfere with the study objectives.
- Subjects with significant signs of access recirculation as judged by the treating physician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automated Setting of Individualized Sodium Technology (ASIST) - Proof of Principle Study
The ASIST study is a medical device study testing the safety and efficacy of a new hemodialysis machine software in chronic haemodialysis patients. The software's intention is to reduce hemodialysis related symptoms such as unwell being, blood pressure changes by adapting the dialysis fluid ion concentration to the patients plasma ion concentration by conductivity measurement.
- Conditions
- End Stage Renal Disease (ESRD)
- Being tested
- Artis Haemodialysis Machine w/ ASIST Software - Isonatremic, Artis Haemodialysis Machine w/ ASIST Software - Isotonic, Artis Haemodialysis Machine w/o ASIST Software
- Keywords
- Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD), Chronic Hemodialysis, In-center HD, Sodium, Isotonic Dialysis
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artis Haemodialysis Machine w/ ASIST Software - IsonatremicDevice
Artis Haemodialysis Machine w/ ASIST Software - IsotonicDevice
Artis Haemodialysis Machine w/o ASIST SoftwareDevice
| Study group | Role | What they receive |
|---|---|---|
| ASIST A | Experimental | Artis Haemodialysis Machine w/ ASIST Software - Isonatremic Receives: Device: Artis Haemodialysis Machine w/ ASIST Software - Isonatremic |
| ASIST B | Experimental | Artis Haemodialysis Machine w/ ASIST Software - Isotonic Receives: Device: Artis Haemodialysis Machine w/ ASIST Software - Isotonic |
| Conventional HD | Active comparator | Artis Haemodialysis Machine w/o ASIST Software Receives: Device: Artis Haemodialysis Machine w/o ASIST Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Blood Pressure
Measured: Up to 9 weeks
Evaluation of Heart Rate
Measured: Up to 9 weeks
Occurrence of Hypotensive Episodes
Measured: Up to 9 weeks
Change in Plasma Sodium
Measured: Up to 9 weeks
Change in Plasma Tonicity
Measured: Up to 9 weeks
Change in MCV (Erythrocyte Mean Corpuscular Volume)
Measured: Up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease (ESRD)Studies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795286
- Sponsor's protocol ID
- 1407-005
- Acronym
- ASIST
- Status last verified
- Mar 2025
- First submitted
- 17 May 2016
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Setting of Individualized Sodium Technology (ASIST) - Proof of Principle Study
- ClinicalTrials.gov ID
- NCT02795286
- Acronym / sponsor ID
- ASIST / 1407-005
- Conditions
- End Stage Renal Disease (ESRD)
- Keywords
- Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD), Chronic Hemodialysis, In-center HD, Sodium, Isotonic Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Mar 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 10 Jun 2016 (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 ASIST study is a medical device study testing the safety and efficacy of a new hemodialysis machine software in chronic haemodialysis patients. The software's intention is to reduce hemodialysis related symptoms such as unwell being, blood pressure changes by adapting the dialysis fluid ion concentration to the patients plasma ion concentration by conductivity measurement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASIST A | Experimental | Device: Artis Haemodialysis Machine w/ ASIST Software - IsonatremicArtis Haemodialysis Machine w/ ASIST Software - Isonatremic |
| ASIST B | Experimental | Device: Artis Haemodialysis Machine w/ ASIST Software - IsotonicArtis Haemodialysis Machine w/ ASIST Software - Isotonic |
| Conventional HD | Active comparator | Device: Artis Haemodialysis Machine w/o ASIST SoftwareArtis Haemodialysis Machine w/o ASIST Software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must be in clinically stable condition as judged by the treating physician, and demonstrated by stable medical history, physical examination, and laboratory testing for 30 days prior to enrollment.
- Subject must be receiving HD or hemodiafiltration (HDF) for at least 30 days prior to study enrollment, be dialyzing a minimum of 3 times per week in an in-center setting and each treatment session must be between 3.5 and 5 hours in duration.
- Subject has a stable functioning vascular access (arteriovenous [AV] fistula, graft, or dual-lumen tunneled catheter) based on the judgment of the treating physician and is performing dual-needle therapy with an actual blood flow rate of 250 - 400 mL/min.
- Subject has a pre-dialysis plasma sodium of ≥132 mmol/L for at least 60 days prior to study enrollment.
- Subject has achieved a dialysis dose of stdKt/Vurea ≥ 2.1 within 60 days prior to enrollment.
Key exclusion criteria (4 listed)
- Female subjects who are pregnant, lactating, or planning to become pregnant during the study period.
- Subjects who have a significant psychiatric disorder or mental disability that could interfere with the subject's ability to provide Informed Consent and/or comply with protocol procedures.
- Subjects with a medical condition that the investigator thinks may interfere with the study objectives.
- Subjects with significant signs of access recirculation as judged by the treating physician.
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 |
|---|---|---|
| Artis Haemodialysis Machine w/ ASIST Software - Isonatremic | Device | ASIST A |
| Artis Haemodialysis Machine w/ ASIST Software - Isotonic | Device | ASIST B |
| Artis Haemodialysis Machine w/o ASIST Software | Device | Conventional HD |
Primary outcome
Evaluation of Blood Pressure
Time frame: Up to 9 weeks
Evaluation of Heart Rate
Time frame: Up to 9 weeks
Occurrence of Hypotensive Episodes
Time frame: Up to 9 weeks
Change in Plasma Sodium
Time frame: Up to 9 weeks
Change in Plasma Tonicity
Time frame: Up to 9 weeks
Change in MCV (Erythrocyte Mean Corpuscular Volume)
Time frame: Up to 9 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 13 Mar 2025.
- 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.
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 Artis Haemodialysis Machine w/ ASIST Software - Isonatremic, Artis Haemodialysis Machine w/ ASIST Software - Isotonic and Artis Haemodialysis Machine w/o ASIST Software in people with End Stage Renal Disease (ESRD), run by Vantive Health LLC at 1 site in Sweden.
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 4 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 13 Mar 2025. 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 Sweden. 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?
Evaluation of Blood Pressure (time frame: Up to 9 weeks). The study lists 6 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 13 Mar 2025.