Status unknownNCT06086470Updated Oct 25, 2023

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

An interventional study of Qidni/D Hemodialysis System in Kidney Disease, End-Stage, sponsored by Qidni Labs Inc.. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-25.

Sponsored by Qidni Labs Inc. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

Registered 4 months after the study started (first participant enrolled May 2023, registered Sep 2023).

Phase: Not applicable
Study type: Interventional
Enrollment: 30
Allocation: Not applicable
Ages: 18 Years to 75 Years
Sex: All

Study 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 studied

Kidney Disease, End-Stage

Browse trials for

Kidney Failure, Chronic 2,121

Keywords

Hemodialysis

In context

Kidney Failure, Chronic

2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.

This study's planned enrollment of 30 is below the median of 55 across 1,582 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

This is the only study on the registry with Qidni Labs Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 30 participants (estimated)

Study arms

Experimental
Experimental Treatment Arm
Patients will receive one treatment of hemodialysis through the Qidni/D Hemodialysis System.
Device: Qidni/D Hemodialysis System

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: 3 days

Secondary outcomes

Efficacy of dialysis
Evaluate the adequacy of dialysis achieved with the Qidni/D device by assessing the change of urea between start and end of dialysis, and compare it to subject's dialysis history.
Time frame: 1 day
Efficacy of dialysis
Evaluate the effectiveness of the Qidni/D device in terms of its ability to adequately remove waste products from the subject's blood. This is assessed by the incidence of serum potassium within target range (as established by laboratory normal values) at the end of dialysis treatment.
Time frame: 1 day
Efficacy of dialysis
Evaluate the adequacy of dialysis achieved with the Qidni/D device by assessing the change of serum creatinine between start and end of dialysis.
Time frame: 1 day
Efficacy of dialysis
Evaluate the adequacy of dialysis with respect to middle molecule clearance achieved with the Qidni/D device by assessing the change of serum beta-2 microglobulin between start and end of dialysis.
Time frame: 1 day
Efficacy of dialysis
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.
Time frame: 1 day
Hemodynamic stability
Incidence of intradialytic hypotension measured by intradialytic blood pressure less than 90 mmHg systolic with associated symptoms (nausea, vomiting, sweating, dizziness, chest pain).
Time frame: 1 day
Technical performance of the Qidni/D device
Number of dialysis sessions interrupted or discontinued due to device malfunction.
Time frame: 1 day

Study locations

1 of 1 sites recruiting

Qidni Labs
Kitchener, Ontario, Canada
- Morteza Ahmadi, PhD · Contact · ma@qidni.com · 2266060956
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06086470
Lead sponsor: Qidni Labs Inc.
Responsible party: Sponsor
First posted: Oct 17, 2023
Start date: May 1, 2023
Primary completion: Jul 14, 2024 (estimated)
Completion: Jul 14, 2024 (estimated)
Last update: Oct 25, 2023

Study contacts

Morteza Ahmadi, PhD

Contact

ma@qidni.com

2266060956

Sandra Nuttin, RN CNephc

Contact

sandra@qidni.com

Peter Margetts, MD

principal investigator · McMaster University

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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