Kidney Disease, End-StageNCT06086470
Evaluating the Use of the Qidni/D Hemodialysis System by Subjects With End-Stage Renal Disease
A study testing Qidni/D Hemodialysis System in people with Kidney Disease, End-Stage, run by Qidni Labs Inc. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Disease, End-Stage
- What is being tested?
- Qidni/D Hemodialysis System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2023to 14 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Sandra Nuttin, RN CNephc contact
Canada1 site, 1 recruiting
- Recruiting
Qidni Labs
Kitchener, Ontario
Morteza Ahmadi, PhD, 2266060956, ma@qidni.com
About this study
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
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
- Being tested
- Qidni/D Hemodialysis System
- Keywords
- Hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qidni/D Hemodialysis SystemDevice
Qidni/D is a hemodialysis device for patients with end-stage renal disease.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment Arm | Experimental | Patients will receive one treatment of hemodialysis through the Qidni/D Hemodialysis System. Receives: Device: Qidni/D Hemodialysis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 1 day
Technical performance of the Qidni/D device
Number of dialysis sessions interrupted or discontinued due to device malfunction.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 May 2023
- Primary completion14 Jul 2024 (estimated)
- Study completion14 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Disease, End-StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-center, non-randomized study. All participants are enrolled into a single group to be treated with the experimental device.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qidni Labs Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Margetts, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086470
- Sponsor's protocol ID
- 00061120
- Status last verified
- Oct 2023
- First submitted
- 28 Sep 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06086470
- Acronym / sponsor ID
- 00061120
- Conditions
- Kidney Disease, End-Stage
- Keywords
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Qidni Labs Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 14 Jul 2024 (estimated)
- Study completion
- 14 Jul 2024 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-center, non-randomized study. All participants are enrolled into a single group to be treated with the experimental device.
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment Arm | Experimental | Device: Qidni/D Hemodialysis SystemPatients will receive one treatment of hemodialysis through the Qidni/D Hemodialysis System. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qidni/D Hemodialysis SystemQidni/D is a hemodialysis device for patients with end-stage renal disease. | Device | Experimental Treatment Arm |
Primary outcome
Incidence and severity of adverse events associated with the use of the Qidni/D device
Time frame: 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.
7 secondary outcomes
Efficacy of dialysis
Time frame: 1 day
Efficacy of dialysis
Time frame: 1 day
Efficacy of dialysis
Time frame: 1 day
Efficacy of dialysis
Time frame: 1 day
Efficacy of dialysis
Time frame: 1 day
Hemodynamic stability
Time frame: 1 day
Technical performance of the Qidni/D device
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Nuttin, RN CNephc contact
Peter Margetts, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qidni/D Hemodialysis System in people with Kidney Disease, End-Stage, run by Qidni Labs Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morteza Ahmadi, PhD (2266060956, ma@qidni.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events associated with the use of the Qidni/D device (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.