- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06086470
Evaluating the Use of the Qidni/D Hemodialysis System by Subjects With End-Stage Renal Disease
October 23, 2023 updated by: Qidni Labs Inc.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Morteza Ahmadi, PhD
- Phone Number: 2266060956
- Email: ma@qidni.com
Study Contact Backup
- Name: Sandra Nuttin, RN CNephc
- Email: sandra@qidni.com
Study Locations
-
-
Ontario
-
Kitchener, Ontario, Canada
- Recruiting
- Qidni Labs
-
Contact:
- Morteza Ahmadi, PhD
- Phone Number: 2266060956
- Email: ma@qidni.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Treatment Arm
Patients will receive one treatment of hemodialysis through the Qidni/D Hemodialysis System.
|
Qidni/D is a hemodialysis device for patients with end-stage renal disease.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of dialysis
Time Frame: 1 day
|
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.
|
1 day
|
Efficacy of dialysis
Time Frame: 1 day
|
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.
|
1 day
|
Efficacy of dialysis
Time Frame: 1 day
|
Evaluate the adequacy of dialysis achieved with the Qidni/D device by assessing the change of serum creatinine between start and end of dialysis.
|
1 day
|
Efficacy of dialysis
Time Frame: 1 day
|
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.
|
1 day
|
Efficacy of dialysis
Time Frame: 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.
|
1 day
|
Hemodynamic stability
Time Frame: 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).
|
1 day
|
Technical performance of the Qidni/D device
Time Frame: 1 day
|
Number of dialysis sessions interrupted or discontinued due to device malfunction.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Margetts, MD, McMaster University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Estimated)
July 14, 2024
Study Completion (Estimated)
July 14, 2024
Study Registration Dates
First Submitted
September 28, 2023
First Submitted That Met QC Criteria
October 10, 2023
First Posted (Actual)
October 17, 2023
Study Record Updates
Last Update Posted (Actual)
October 25, 2023
Last Update Submitted That Met QC Criteria
October 23, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00061120
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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