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

September 8, 2025 updated by: B.Braun Avitum AG

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Recruiting
        • Policlinico S. Orsola - Malpighi - UOC Nefrologia, Dialisi e Ipertensione
        • Contact:
          • Annalisa Zucchelli, Prof.
        • Principal Investigator:
          • Annalisa Zucchelli, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BioLogic Fusion followed by standard dialysis
Patients will be dialysed first with the BioLogic Fusion feature activated and then switched to standard dialysis with the BioLogic Fusion feature de-activated
Device: BioLogic Fusion
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.
Experimental: Standard dialysis followed by BioLogic Fusion
Patients will be dialysed first with standard dialysis with the BioLogic Fusion feature de-activated and then switched to the BioLogic Fusion feature activated
Device: BioLogic Fusion
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-dialysis body weight
Time Frame: 12 weeks
percentage of sessions with reached prescribed post-dialysis body weight
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B.Braun Avitum AG

Investigators

  • Principal Investigator: Annalisa Zucchelli, MD, University Hospital Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA-G-H-1604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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