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

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)
• 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 medicaldevices studies)
• Vascular access insufficiency (mean blood flow <200ml/min)
• Patients treated with dialysis profiles: sodium profile, Ultrafiltration (UF) profile,and temperature profile
• Use of the BioLogic fusion function during the last 9 dialysis sessions recorded atthe site (retrospective screening period)
• Pregnant or nursing women. Women of childbearing potential must agree to avoidpregnancy 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 theInstructions for Use (IFU)
• Any serious medical condition or disability, which in the opinion of the investigatorlimits the life expectancy and would preclude completion of the study