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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Qidni Labs Inc.Lead Sponsor

Peter Margetts, MDPrincipal InvestigatorMcMaster University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limitation for this medical experiment include individuals forty and over?

"This clinical trial is open for people from 18 years of age to 75 years old."

Answered by AI

What are the criteria for participants in this trial?

"Individuals who possess a diagnosis of kidney disease and are between 18 to 75 years old can participate in this trial. 30 patients need to be recruited for the completion of this research project."

Answered by AI

Is this experimentation currently recruiting participants?

"According to information on clinicaltrials.gov, this medical study is actively enlisting participants who meet the criteria for enrollment. The trial was launched on May 1st 2023 and has since been amended as of October 10th 2023."

Answered by AI

What is the total number of participants enrolled in this experiment?

"Yes, the clinicaltrials.gov database shows that this trial is still recruiting participants. It was first launched on May 1st 2023 and has been receiving updates as recently as October 10th 2023. The study seeks 30 volunteers from a singular medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Evaluating the Use of the Qidni/D Hemodialysis System by Subjects With End-Stage Renal Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06086470.