Evaluating the Use of the Qidni/D Hemodialysis System by Subjects With End-Stage Renal Disease

A Prospective Single-Center, Open Label, Non-Randomized Study Evaluating the Use of the Qidni/D Hemodialysis System by Subjects With End-Stage Renal Disease

The main goal of this clinical study is to evaluate the safety of the Qidni/D Hemodialysis System in patients with end-stage renal disease. The main question it aims to answer is:

Is the Qidni/D safe for performing hemodialysis?

Participants will be subjected to one treatment of hemodialysis for up to 4 hours with the use of the Qidni/D.

Inclusion Criteria:

• Subject has provided informed consent.
• Subject is at least 18 years and less than 75 years of age.
• Subject has end-stage renal disease adequately treated by maintenance dialysis and has been deemed stable for at least three months by his/her treating nephrologist.
• Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min for conventional treatment or 200-250 mL/min for nocturnal hemodialysis treatment.
• Subject understands the nature of the procedures and the requirements of the study protocol.
• Subject is willing and able to comply with the protocol requirements and return to the treatment center for all required treatments and clinical evaluations.
• Subject has no childbearing potential or the Subject affirms they are not pregnant. Subject affirms using contraception measures to prevent potential pregnancies during the study period.

Exclusion Criteria:

• Subject is unable to read English.
• Subject has dementia or lacks capacity for self-care.
• Life expectancy less than 12 months from first study procedure.
• Subject unable to understand or cooperate with the hemodialysis nurse and dialysis care team.
• Subject has a documented history of non-adherence to dialysis therapy that would prevent successful completion of the study.
• Subject has had a recent major cardiovascular adverse event within the last 3 months.
• Subject has a persistent pre-dialysis sitting systolic blood pressure less than 100 mmHg despite medical therapy.
• Subject has ongoing, symptomatic intra-dialytic hypotension requiring medical intervention.
• Subject has an active infection requiring antibiotics within the last 7 days.
• Subject with fluid overload due to intractable ascites secondary to liver cirrhosis.
• Subject is seroreactive for Hepatitis B Surface Antigen.
• Subject has a history of adverse reactions to dialyzer membrane material.
• Subject is participating in another investigative drug or device clinical study related to dialysis which conflicts with the execution of this study.
• Subject is scheduled to receive an organ transplant during the course of the study: paired exchange or living donor.
• Subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol.
• Any other documented condition that the Investigator feels would prevent the Subject from successful inclusion in the study.
• Subject has an active viral infection (eg. COVID-19).
• Subject is on peritoneal dialysis.