Evaluating the Qidni/D Hemodialysis System for patients 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

This study is testing a new hemodialysis system to see if it's safe for people with end-stage kidney disease during their treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Qidni Labs Inc. (industry)
• Locations: 1 site (Kitchener, Ontario)
• Trial ID: NCT06086470 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the safety of the Qidni/D Hemodialysis System in individuals suffering from end-stage renal disease. Participants will undergo a single hemodialysis treatment lasting up to four hours using the Qidni/D system. The primary focus is to determine whether this new system is safe for performing hemodialysis in this patient population. The study will involve monitoring participants for any adverse effects during and after the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with stable end-stage renal disease who are currently undergoing maintenance dialysis.

Not a fit: Patients who are unable to read English or those with unstable vascular access may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer hemodialysis option for patients with end-stage renal disease.

How similar studies have performed: While this approach is novel, similar studies evaluating new hemodialysis systems have shown promise in improving patient safety and outcomes.

Eligibility criteria

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.

Where this trial is running

Kitchener, Ontario

• Qidni Labs — Kitchener, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Peter Margetts, MD — McMaster University
• Study coordinator: Morteza Ahmadi, PhD

Conditions: Kidney Disease, End-Stage, Hemodialysis