Kidney Disease, End-Stage
Conditions
Keywords
Hemodialysis
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.
Interventions
DEVICEQidni/D Hemodialysis System
Qidni/D is a hemodialysis device for patients with end-stage renal disease.
Sponsors
Qidni Labs Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single-center, non-randomized study. All participants are enrolled into a single group to be treated with the experimental device.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events associated with the use of the Qidni/D device | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic stability | 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). |
| Efficacy of dialysis | 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. |
| Technical performance of the Qidni/D device | 1 day | Number of dialysis sessions interrupted or discontinued due to device malfunction. |
Countries
Canada
Contacts
Primary ContactMorteza Ahmadi, PhD
Backup ContactSandra Nuttin, RN CNephc
Outcome results
None listed