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

NCT06086470 | Unknown

• 1 other identifier: 00061120
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Disease, End-Stage

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events associated with the use of the Qidni/D device

  Adverse events will be recorded and adjudicated independently as to the severity and likelihood of association with treatment with the Qidni/D device.

  3 days

Secondary Outcomes (7)

• Efficacy of dialysis

  1 day

• Efficacy of dialysis

  1 day

• Efficacy of dialysis

  1 day

• Efficacy of dialysis

  1 day

• Efficacy of dialysis

  1 day

Study Arms (1)

Experimental Treatment Arm

EXPERIMENTAL

Patients will receive one treatment of hemodialysis through the Qidni/D Hemodialysis System.

Device: Qidni/D Hemodialysis System

Interventions

Qidni/D Hemodialysis System DEVICE

Qidni/D is a hemodialysis device for patients with end-stage renal disease.

Experimental Treatment Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qidni Labs Inc.: lead

Study Sites (1)

Qidni Labs

Kitchener, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Margetts, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morteza Ahmadi, PhD

CONTACT

2266060956; ma@qidni.com

Sandra Nuttin, RN CNephc

CONTACT

sandra@qidni.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, non-randomized study. All participants are enrolled into a single group to be treated with the experimental device.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 17, 2023
• Study Start: May 1, 2023
• Primary Completion: July 14, 2024
• Study Completion: July 14, 2024
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

CA (1)