Recruiting

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

Sponsor:

Qidni Labs Inc.

Code:

NCT06086470

Conditions

Kidney Disease, End-Stage

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Qidni/D Hemodialysis System

Study Details

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.

Conditions

Kidney Disease, End-Stage

Study ID

NCT06086470

Start date

May 1, 2023

Status verified date

Oct, 2023

Completion date

Jul 14, 2024

Anticipated

Primary completion date

Jul 14, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Treatment Arm

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

Interventions

Qidni/D Hemodialysis System

Qidni/D is a hemodialysis device for patients with end-stage renal disease.

Primary outcome measure

Incidence and severity of adverse events associated with the use of the Qidni/D device [ Time Frame: 3 days ]

Central Contacts and Locations

Central contacts

Morteza Ahmadi, PhD

2266060956 ma@qidni.com

Sandra Nuttin, RN CNephc

sandra@qidni.com

Locations

Qidni Labs

Recruiting

Kitchener, Ontario, Canada

Contacts

Morteza Ahmadi, PhD

2266060956 ma@qidni.com

More Information

Sponsor

Qidni Labs Inc.

Last update posted

Oct 25, 2023

Last verified

Oct, 2023

Keywords

Hemodialysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Qidni Labs Inc. on 2023-10-25.