Qidni/D Hemodialysis System for Chronic Kidney Failure

Recruiting in Palo Alto (17 mi)

Overseen byPeter Margetts, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Qidni Labs Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

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.

I have been on stable dialysis for my end-stage kidney disease for at least 3 months.

I am willing and able to follow the study rules and visit the treatment center as needed.

+4 more

Exclusion Criteria

You have tested positive for Hepatitis B Surface Antigen.

I am scheduled for an organ transplant from a living donor or through paired exchange.

I have had a major heart problem in the last 3 months.

+15 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Experimental Treatment ArmExperimental Treatment1 Intervention

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