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.
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