Overview
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.
Eligibility
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.