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Study identifier: NCT06376968 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Renal Dialysis  ·  Sponsor: B.Braun Avitum AG

PhaseNA
Planned participants56
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

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.

This description comes directly from the study's public registry record.

Talk to the study team

Strube Frank  ·  +4915257240618  ·  frank.strube@bbraun.com

Seebode Christina, Dr.  ·  christina.seebode@bbraun.com

Always discuss trial participation with your own doctor first.

Locations (1)

Policlinico S. Orsola - Malpighi - UOC Nefrologia, Dialisi e IpertensioneBologna, Emilia-Romagna, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT06376968