Renal DialysisNCT06376968
Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis
A study testing BioLogic Fusion in people with Renal Dialysis, run by B.Braun Avitum AG at 1 site in Italy.
Trial summary
The goal of this prospective, randomized, controlled, cross-over, multicentric study is to demonstrate the safety of bioLogic Fusion in patients on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Dialysis
- What is being tested?
- BioLogic Fusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 22 Apr 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male or female subjects ≥18 years of age
- Chronic bicarbonate standard high-flux haemodialysis or hemodiafiltration for at least 3 months
- Dialysis frequency 3 x per week
- Dialysis duration per session ≥ 4h
- Patient on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes
- No residual renal function (definition: ≤100 ml urine/day) - changed to "No to minimal residual renal function (definition: ≤ 300 ml/day)" with Amendment 1 (CIP version 6)
- Stable dry body weight for at least 4 weeks
- Subjects who are willing to give a voluntary consent to participate in the study
Who cannot join
- Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
- Vascular access insufficiency (mean blood flow <200ml/min)
- Patients treated with dialysis profiles: sodium profile, Ultrafiltration (UF) profile, and temperature profile - changed to: " Patients treated with dialysis profiles during the 9 prescreening visits: sodium profile, UF profile, and temperature profile. However, patients on sodium, ultrafiltration or temperature profiling expected to reduce intradialytic hypotensive episodes can be evaluated for enrollment when their frequency of sessions complicated by hypotension demonstrate the lack of efficacy of the applied profiles" with Amendment 1 (CIP version 6)
- Use of the BioLogic fusion function during the last 9 dialysis sessions recorded at the site (retrospective screening period)
- Pregnant or nursing women. Women of childbearing potential must agree to avoid pregnancy during the study period
- Factors which may interfere with full participation in the trial
- Any contra-indication to haemodialysis treatment per se, as described in the Instructions for Use (IFU)
- Any serious medical condition or disability, which in the opinion of the investigator limits the life expectancy and would preclude completion of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Seebode Christina, Dr. contact
Italy1 site, 1 recruiting
- Recruiting
Policlinico S. Orsola - Malpighi - UOC Nefrologia, Dialisi e Ipertensione
Bologna, Emilia-Romagna, 40138
Annalisa Zucchelli, Prof.
Annalisa Zucchelli, Prof.
About this study
The goal of this prospective, randomized, controlled, cross-over, multicentric study is to demonstrate the safety of bioLogic Fusion in patients on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes. The main question it aims to answer is:
- Which is the number and percentage of individual sessions with reached prescribed post-dialysis body weight in the prescribed treatment time in each single session in hypotensive-prone patients on high-flux haemodialysis or hemodiafiltration within each patient with treatments performed with DialogiQ with (treatment A) or without (treatment B) the bioLogic Fusion option activated? Participants will in addition to their routine dialysis treatment undergo 2 physical examinations and regularly answer questionnaires.
A crossover design is used to compare treatments with or without the BioLogic Fusion function activated.
- Conditions
- Renal Dialysis
- Being tested
- BioLogic Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioLogic FusionDevice
Dialysis conducted with Dialog iQ dialysis machine either using the BioLogic Fusion option or not using it. This is only a biologic feedback system using blood pressure and residual blood volume as parameters to predict potential hypotensive episodes. If switched off, standard dialysis treatment happens, if switched on, the system tries to predict and prevent hypotensive episodes.
Intervention duration in total 28 weeks - 12 weeks standard treatment, 4 weeks learning phase BioLogic Fusion, 12 weeks BioLogic Fusion
| Study group | Role | What they receive |
|---|---|---|
| BioLogic Fusion followed by standard dialysis | Experimental | Patients will be dialysed first with the BioLogic Fusion feature activated and then switched to standard dialysis with the BioLogic Fusion feature de-activated Receives: Device: BioLogic Fusion |
| Standard dialysis followed by BioLogic Fusion | Experimental | Patients will be dialysed first with standard dialysis with the BioLogic Fusion feature de-activated and then switched to the BioLogic Fusion feature activated Receives: Device: BioLogic Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-dialysis body weight
percentage of sessions with reached prescribed post-dialysis body weight
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start22 Apr 2024
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B.Braun Avitum AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annalisa Zucchelli, MD, Principal investigator, University Hospital Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376968
- Sponsor's protocol ID
- BA-G-H-1604
- Status last verified
- Sep 2026
- First submitted
- 16 Apr 2024
- Last updated
- 30 Sep 2026
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis
- ClinicalTrials.gov ID
- NCT06376968
- Acronym / sponsor ID
- BA-G-H-1604
- Conditions
- Renal Dialysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- B.Braun Avitum AGIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Apr 2024 (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.
The goal of this prospective, randomized, controlled, cross-over, multicentric study is to demonstrate the safety of bioLogic Fusion in patients on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes. The main question it aims to answer is:
- Which is the number and percentage of individual sessions with reached prescribed post-dialysis body weight in the prescribed treatment time in each single session in hypotensive-prone patients on high-flux haemodialysis or hemodiafiltration within each patient with treatments performed with DialogiQ with (treatment A) or without (treatment B) the bioLogic Fusion option activated? Participants will in addition to their routine dialysis treatment undergo 2 physical examinations and regularly answer questionnaires.
A crossover design is used to compare treatments with or without the BioLogic Fusion function activated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioLogic Fusion followed by standard dialysis | Experimental | Device: BioLogic FusionPatients will be dialysed first with the BioLogic Fusion feature activated and then switched to standard dialysis with the BioLogic Fusion feature de-activated |
| Standard dialysis followed by BioLogic Fusion | Experimental | Device: BioLogic FusionPatients will be dialysed first with standard dialysis with the BioLogic Fusion feature de-activated and then switched to the BioLogic Fusion feature activated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects ≥18 years of age
- Chronic bicarbonate standard high-flux haemodialysis or hemodiafiltration for at least 3 months
- Dialysis frequency 3 x per week
- Dialysis duration per session ≥ 4h
- Patient on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes
Key exclusion criteria (8 listed)
- Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
- Vascular access insufficiency (mean blood flow <200ml/min)
- Patients treated with dialysis profiles: sodium profile, Ultrafiltration (UF) profile, and temperature profile - changed to: " Patients treated with dialysis profiles during the 9 prescreening visits: sodium profile, UF profile, and temperature profile. However, patients on sodium, ultrafiltration or temperature profiling expected to reduce intradialytic hypotensive episodes can be evaluated for enrollment when their frequency of sessions complicated by hypotension demonstrate the lack of efficacy of the applied profiles" with Amendment 1 (CIP version 6)
- Use of the BioLogic fusion function during the last 9 dialysis sessions recorded at the site (retrospective screening period)
- Pregnant or nursing women. Women of childbearing potential must agree to avoid pregnancy during the study period
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 |
|---|---|---|
| BioLogic FusionDialysis conducted with Dialog iQ dialysis machine either using the BioLogic Fusion option or not using it. This is only a biologic feedback system using blood pressure and residual blood volume as parameters to predict potential hypotensive episodes. If switched off, standard dialysis treatment happens, if switched on, the system tries to predict and prevent hypotensive episodes. Intervention duration in total 28 weeks - 12 weeks standard treatment, 4 weeks learning phase BioLogic Fusion, 12 weeks BioLogic Fusion | Device | BioLogic Fusion followed by standard dialysis, Standard dialysis followed by BioLogic Fusion |
Primary outcome
Post-dialysis body weight
Time frame: 12 weeks
percentage of sessions with reached prescribed post-dialysis body weight
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- 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.
Seebode Christina, Dr. contact
Annalisa Zucchelli, MD principal investigator
University Hospital Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioLogic Fusion in people with Renal Dialysis, run by B.Braun Avitum AG at 1 site in Italy.
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 8 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Strube Frank (+4915257240618, frank.strube@bbraun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-dialysis body weight (time frame: 12 weeks). 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 30 Sep 2026.