Wearable Ultrafiltration Device for Kidney Failure

(RUF-D Trial)

Overseen By Jarrin 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wearable device designed to assist kidney failure patients who struggle with fluid removal during dialysis. The device, called RUF-D, gently removes excess fluid between hospital dialysis sessions, potentially reducing stress on the body and minimizing organ damage. It targets individuals who regularly undergo hemodialysis (a process to filter waste and water from the blood) three times a week but still face challenges in managing fluid levels. Those who often feel unwell after dialysis due to fluid buildup or removal may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance dialysis care.

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 prior data suggests that this wearable ultrafiltration device is safe for kidney failure patients?

Research has shown that studies have been conducted on wearable devices like the RUF-D, which help remove excess fluid from the body. These devices operate more gently than traditional dialysis, which can sometimes remove fluid too quickly and harm organs.

The RUF-D is designed to slowly and gently remove fluid between regular dialysis sessions. Similar devices have shown promise in reducing stress on the body. However, specific safety information for the RUF-D is not yet available.

This trial is labeled as "Not Applicable" for its phase, indicating that detailed safety data might not be ready. Early trials typically focus on safety and device tolerance, so this trial likely gathers important information on how people handle it.

In summary, the wearable device is being tested to determine if it can remove fluid more gently, potentially offering a safer alternative to traditional methods. More studies are needed to better understand its safety for regular use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the wearable ultrafiltration device, RUF-D, because it offers a gentler way to remove excess fluid in patients with kidney failure who are undergoing hemodialysis. Unlike traditional dialysis, which often removes large amounts of fluid in a short time, RUF-D provides continuous, gentle fluid removal between dialysis sessions. This new method can help reduce unpleasant symptoms and physical stress associated with rapid fluid removal, making it a promising addition to current kidney failure treatments.

What evidence suggests that this wearable ultrafiltration device is effective for kidney failure?

Research shows that the RUF-D device, a wearable tool, could help manage fluid removal for people on dialysis. In this trial, participants will use the RUF-D device, which offers a gentler method to remove excess fluid between dialysis sessions, potentially reducing the risk of organ damage. Studies have found that removing too much fluid too quickly can harm organs. Earlier research on similar wearable devices has demonstrated effective fluid management without constant hospital visits. This device could ease patients' lives by allowing better control over fluid levels, potentially improving both comfort and lifespan. ^{1 2 3 5 6}

Who Is on the Research Team?

Dr. Christopher McIntyre, MBBS DM

Principal Investigator

London Health Sciences Centre

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I do not have any active infections.

Non-compliance to hemodialysis prescription/schedule

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Patients receiving hemodialysis that struggle with fluid removal during dialysis Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06832696

Assessment of a Wearable Ultrafiltration Device (RUF-D) Our investigators have led the way in showing that taking off too much fluid faster than the body can tolerate causes damage to multiple organ systems; ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7724360/

The efficacy of a wearable hemodialysis with tentative ... The aim of this study was to find an effective and simple method by which outpatient hemodialysis can be performed using diffusion and ultrafiltration methods.

3. withpower.com withpower.com/trial/phase-ultrafiltration-2-2025-c0bc9

Wearable Ultrafiltration Device for Kidney Failure (RUF-D ... What data supports the effectiveness of the treatment RUF-D for kidney failure? Research on wearable ultrafiltration devices, like the Wearable Artificial ...

4. insight.jci.org insight.jci.org/articles/view/86397

A wearable artificial kidney for patients with end-stage ... We conducted a FDA-approved human trial of a wearable artificial kidney, a miniaturized, wearable hemodialysis machine, based on dialysate-regenerating sorbent ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6452182/

Wearable artificial kidney and wearable ultrafiltration device ... The only clinical data available is from a study involving six centres and 13 implanted devices. A mean blood flow of 364 mL/min (ranging from ...

6. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-024-03929-9

Measuring fluid balance in end-stage renal disease with a ... The aim of this study was to investigate the ability of a wearable continuous bioimpedance sensor to detect changes in fluid volume in patients undergoing ...