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

Primary Purpose

Kidney Disease, End-Stage

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Qidni/D Hemodialysis System
Sponsored by
Qidni Labs Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Disease, End-Stage focused on measuring Hemodialysis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Qidni LabsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Treatment Arm

Arm Description

Patients will receive one treatment of hemodialysis through the Qidni/D Hemodialysis System.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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).
Technical performance of the Qidni/D device
Number of dialysis sessions interrupted or discontinued due to device malfunction.

Full Information

First Posted
September 28, 2023
Last Updated
October 23, 2023
Sponsor
Qidni Labs Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06086470
Brief Title
Evaluating the Use of the Qidni/D Hemodialysis System by Subjects With End-Stage Renal Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
July 14, 2024 (Anticipated)
Study Completion Date
July 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qidni Labs Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease, End-Stage
Keywords
Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Treatment Arm
Arm Type
Experimental
Arm Description
Patients will receive one treatment of hemodialysis through the Qidni/D Hemodialysis System.
Intervention Type
Device
Intervention Name(s)
Qidni/D Hemodialysis System
Intervention Description
Qidni/D is a hemodialysis device for patients with end-stage renal disease.
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events associated with the use of the Qidni/D device
Description
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 Outcome Measure Information:
Title
Efficacy of dialysis
Description
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
Title
Efficacy of dialysis
Description
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
Title
Efficacy of dialysis
Description
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
Title
Efficacy of dialysis
Description
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
Title
Efficacy of dialysis
Description
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
Title
Hemodynamic stability
Description
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
Title
Technical performance of the Qidni/D device
Description
Number of dialysis sessions interrupted or discontinued due to device malfunction.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morteza Ahmadi, PhD
Phone
2266060956
Email
ma@qidni.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Nuttin, RN CNephc
Email
sandra@qidni.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Margetts, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qidni Labs
City
Kitchener
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morteza Ahmadi, PhD
Phone
2266060956
Email
ma@qidni.com

12. IPD Sharing Statement

Learn more about this trial

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

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