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

Qidni Labs

Status

Enrolling

Conditions

Kidney Disease, End-Stage

Treatments

Device: Qidni/D Hemodialysis System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06086470

00061120

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.