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Home dialysis device gets safety check in ongoing study

NCT ID NCT04198012

Disease control Sponsor: Deka Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study allowed 25 people with end-stage kidney disease to keep using the HemoCare hemodialysis system at home while the device was being reviewed for market approval. The main goal was to track safety events like side effects or device problems. Participants needed a trained care partner to help with treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HemoCare™ Hemodialysis System (a device for home hemodialysis)
What this could lead to
If successful, this could help make home hemodialysis more accessible for people with kidney failure, offering more flexibility and convenience.
What could go wrong
This is a small, completed study focused on continued access and safety monitoring, not a test of new benefits. The device still requires a trained care partner and may not suit everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

25 people

The number who actually took part.

Started

Dec 2019

Finished

Apr 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Completed DEKA Protocol DKPL 00057 001 and are qualified to enter the study based on the assessment of the Investigator. * Are willing to comply and capable of complying with the study requirements for therapy with the HemoCare™ Hemodialysis System. * Have a trained study care partner able to support subject for all at-home study treatments. * Subject and care partner can read and understand English and provide written informed consent. * Have a stable functioning vascular access as judged by the treating physician. Exclusion Criteria: * Have a current self-reported pregnancy or are actively planning to become pregnant within the next 12 months, lactating, or not using medically acceptable means of contraception during the study. * Have any any other clinically significant medical disease or condition or subject responsibility that, in the Investigator's opinion, may interfere with a subject's (and/or care partner's) ability to give informed consent, adhere to the protocol, interfere with assessment of the investigational product (IP), or serve as a contraindication to the subject's participation in the study. * Have a significant psychiatric disorder or mental disability that could interfere with the subject's ability to provide informed consent and/or comply with study procedures. * Are participating or planning to participate in any other interventional studies except DKPL-00057-001.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

End-stage renal disease

Contacts and locations

Locations

  • DCI North Brunswick

    North Brunswick, New Jersey, 08902, United States

  • Dialysis Clinic, Inc.

    Knoxville, Tennessee, 37920, United States

  • Dialysis Clinic, Inc.

    Nashville, Tennessee, 37203, United States

  • The Rogosin Institute

    New York, New York, 11021, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39213, United States

  • Wellbound North Austin

    Austin, Texas, 78758, United States

  • Wellbound South Austin

    Austin, Texas, 78744, United States

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