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

Not Applicable

Recruiting

• Conditions: Kidney Disease, End-Stage

• Registration Number: NCT06086470
• Lead Sponsor: Qidni Labs Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-09-28
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-17
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25
• Primary Completion: 2024-07-14
• Study Completion: 2024-07-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events associated with the use of the Qidni/D device	3 days	Adverse events will be recorded and adjudicated independently as to the severity and likelihood of association with treatment with the Qidni/D device.

Secondary Outcome Measures

Name	Time	Method
Efficacy of dialysis	1 day	Evaluate the ability of the Qidni/D device to accurately remove fluid from the subject during dialysis by comparing the device specified targeted fluid removal with the mass of the fluid removed in kilograms.
Hemodynamic stability	1 day	Incidence of intradialytic hypotension measured by intradialytic blood pressure less than 90 mmHg systolic with associated symptoms (nausea, vomiting, sweating, dizziness, chest pain).
Technical performance of the Qidni/D device	1 day	Number of dialysis sessions interrupted or discontinued due to device malfunction.

Trial Locations

Locations (1)

Qidni Labs; 🇨🇦 Kitchener, Ontario, Canada