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

Recruiting N/A Interventional Study
Renal Dialysis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
56 (estimated)
Sponsor
B.Braun Avitum AG · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 hy…
Contacts

Strube Frank

+4915257240618

frank.strube@bbraun.com

CONTACT

Seebode Christina, Dr.

christina.seebode@bbraun.com

CONTACT