Wearable Ultrafiltration Device for Kidney Failure
(RUF-D Trial)

Overseen ByJarrin Penny, RN, PhD, CNeph (C)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Disqualifiers: Active infections, Non-compliance, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment RUF-D for kidney failure?

Research on wearable ultrafiltration devices, like the Wearable Artificial Kidney (WAK) and Wearable Ultrafiltration (WUF) systems, shows they are effective in removing waste and excess fluid from the blood, which is crucial for patients with kidney failure. These devices have been tested in human studies and have shown safety and efficacy, suggesting that similar technologies could be beneficial for kidney failure treatment.¹ ² ³ ⁴ ⁵

Is the Wearable Ultrafiltration Device for Kidney Failure safe for humans?

The Wearable Ultrafiltration Device, also known as the Wearable Artificial Kidney (WAK) and Wearable Ultrafiltration (WUF) system, has been tested in human studies and shown to be safe and effective in removing waste and excess fluid. Although these devices need further technological improvements, their safety in human use has been demonstrated.¹ ⁶ ⁷ ⁸ ⁹

How does the Wearable Ultrafiltration Device for Kidney Failure differ from other treatments?

The Wearable Ultrafiltration Device is unique because it offers a portable and wearable solution for kidney failure, unlike traditional in-center hemodialysis. It uses advanced membrane technology to mimic natural kidney functions, allowing for continuous treatment and potentially improving quality of life by reducing the need for frequent hospital visits.¹ ² ⁸ ¹⁰ ¹¹

What is the purpose of this trial?

Kidney failure is common. In some people the ability of the kidneys to clean poisons out of the blood gets so low they need to be hooked up to a machine three times a week to do it for them. This is called dialysis. Unfortunately, although this treatment removes those waste products, people who need dialysis die much more often than people who don't need dialysis. Dialysis causes extreme stress on the body and leads to many organs being damaged.Removing fluid from the body quickly causes the equivalent of repeated little heart attacks or little strokes in the brain. Many patients struggle to tolerate having all the fluid that they have drunk since their last dialysis session removed- without unpleasant symptoms of dangerously low blood pressure (which makes the damage worse).Dialysis treatments can be done more slowly or more often, but that means having to spend a lot more time at the hospital and is difficult for the health system to be able to provide the extra treatment time.Could extra fluid be removed in between dialysis sessions? Up to now there has not been a way to effectively do this. Investigators have now designed and built an entirely new, very small and very simplified, device that can do part of what a dialysis machine does. It doesn't clean the blood or replace the need for conventional dialysis sessions, but it can provide additional and gentle removal of fluid which wasn't able to be taken off during a standard treatment session.If this study is successful, it will be the first time that a wearable device has been successfully built and used to take off extra fluid when dialysis patients are not in the hospital. The ability to do this opens up the possibility of, 1) helping to treat patients (both making people feel better and live longer) who can't tolerate getting off all the fluid in the short 3-4 hours they are on the dialysis machine in the hospital, and 2) helping patients who feel OK having the fluid taken off but are silently being subjected to damage to their organs due to the rapid removal, have reduced damage.

Research Team

Dr. Christopher McIntyre, MBBS DM

Principal Investigator

London Health Sciences Centre

Eligibility Criteria

This trial is for kidney failure patients who undergo regular dialysis and struggle with removing excess fluid during treatments. It's not suitable for those who can't tolerate additional fluid removal or have conditions that may interfere with the study.

Inclusion Criteria

Willing and able to provide informed consent

I undergo hemodialysis three times a week.

I often gain a lot of weight between dialysis sessions or struggle to reach my target weight with regular treatments.

See 1 more

Exclusion Criteria

I do not have any active infections.

Non-compliance to hemodialysis prescription/schedule

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the RUF-D device for additional fluid removal between dialysis sessions

4 weeks

Regular visits for monitoring and device assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

RUF-D

Trial Overview The trial is testing a new wearable device, RUF-D, designed to gently remove extra fluid between dialysis sessions. The goal is to reduce stress on the body and organ damage caused by rapid fluid removal during standard treatments.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Patients receiving hemodialysis that struggle with fluid removal during dialysisExperimental Treatment1 Intervention

In patients receiving hemodialysis treatment, high amounts of fluid removed in a short time (3-4 hours) can lead to unpleasant symptoms, low blood pressure and can cause bodily stress and organ damage. Leaving this extra fluid in the body also causes undue bodily stress. Investigators need to find gentler, more tolerable ways to remove fluid from patients that need hemodialysis. Our investigators have designed and built a new, very small and very simplified device (RUF-D) that can do part of what a dialysis machine does. It doesn't clean the blood or replace the need for dialysis treatments, but it can provide additional and gentle removal of fluid between dialysis treatments which wasn't able to be taken off during a standard treatment session.