Clinical trial NCT06086470: Evaluating the Use of the Qidni/D Hemodialysis System by Subjects With End-Stage Renal Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Disease, End-Stage
Keywords: Hemodialysis
Lead sponsor: Qidni Labs Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single-center, non-randomized study. All participants are enrolled into a single group to be treated with the experimental device.
Primary purpose: TREATMENT

Brief summary: 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 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.

Primary outcomes:
measure: Incidence and severity of adverse events associated with the use of the Qidni/D device
timeFrame: 3 days
Secondary outcomes:
measure: Efficacy of dialysis
timeFrame: 1 day
measure: Efficacy of dialysis
timeFrame: 1 day
measure: Efficacy of dialysis
timeFrame: 1 day
measure: Efficacy of dialysis
timeFrame: 1 day
measure: Efficacy of dialysis
timeFrame: 1 day
measure: Hemodynamic stability
timeFrame: 1 day
measure: Technical performance of the Qidni/D device
timeFrame: 1 day
Other outcomes:
Locations:
city: Kitchener
country: Canada
facility: Qidni Labs
state: Ontario
Study officials:
affiliation: McMaster University
name: Peter Margetts, MD
role: PRINCIPAL_INVESTIGATOR
References: