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Device

Qidni/D Hemodialysis System for Chronic Kidney Failure

N/A
Recruiting
Led By Peter Margetts, MD
Research Sponsored by Qidni Labs Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is at least 18 years and less than 75 years of age.
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.
Must not have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days
Awards & highlights

Summary

This trial evaluates the safety of the Qidni/D Hemodialysis System for patients with end-stage renal disease. Patients will receive one hemodialysis treatment for up to 4 hours.

Who is the study for?
This trial is for adults aged 18-75 with end-stage renal disease who've been stable on dialysis for at least three months. They must understand the study, agree to use contraception, and have a good vascular access for blood flow. Excluded are those unable to read English, with dementia, severe health issues, non-adherence to dialysis therapy, recent infections or major cardiovascular events.
What is being tested?
The Qidni/D Hemodialysis System is being tested in this study specifically for safety during up to four hours of hemodialysis treatment in patients with severe kidney failure. The main question is whether this system is safe for such treatments.
What are the potential side effects?
While specific side effects aren't listed here, typical risks associated with hemodialysis may include low blood pressure, muscle cramps, itching, sleep problems and anemia. The new system's materials could potentially cause reactions in some patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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My vascular access for dialysis works well and supports the required blood flow.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a major heart problem in the last 3 months.
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My blood pressure stays below 100 mmHg before dialysis, even with medication.
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I experience low blood pressure during dialysis that needs treatment.
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I have been on antibiotics for an infection in the past week.
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I have severe swelling due to fluid buildup from liver cirrhosis.
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I am scheduled for an organ transplant from a living donor or through paired exchange.
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I am not undergoing treatment for a life-threatening cancer that would stop me from completing the study.
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I have dementia or cannot take care of myself.
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I can understand and cooperate with my care team during hemodialysis.
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I currently have an active viral infection like COVID-19.
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I am currently undergoing peritoneal dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and severity of adverse events associated with the use of the Qidni/D device
Secondary study objectives
Efficacy of dialysis
Hemodynamic stability
Technical performance of the Qidni/D device

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental Treatment ArmExperimental Treatment1 Intervention
Patients will receive one treatment of hemodialysis through the Qidni/D Hemodialysis System.

Find a Location

Who is running the clinical trial?

Qidni Labs Inc.Lead Sponsor
Peter Margetts, MDPrincipal InvestigatorMcMaster University
~13 spots leftby Sep 2025
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