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New dialysis machine could let kidney patients treat themselves at home

NCT ID NCT06613568

Disease control Sponsor: Diality Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study is testing a new dialysis machine called Moda-flx for people with end-stage kidney disease who are already on stable dialysis. The goal is to see if the machine is safe and works well both in a clinic and at home when used by trained patients or care partners. About 50 adults aged 18 to 80 will take part. The study compares how well the machine removes waste and fluids, and tracks any side effects.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

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 to 80 years

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: * Are between 18 and 80 years of age and Care Partner is at least 18 years of age at the time of signing consent. * Have a diagnosis of end stage kidney disease (ESKD) adequately treated by maintenance dialysis (defined as achieving a spKt/V ≥ 1.2 OR stdKt/V ≥ 2.1) and be deemed stable by their treating nephrologist prior to the end of the Screening Period * Have a well-functioning and stable vascular access (tunneled central venous catheter arteriovenous fistula, or graft) that allows a blood flow of at least 300 ml/min prior to the end of Screening * Can successfully complete a Skills and Comprehension Assessment with a Care Partner prior to the completion of the Training Period. Exclusion Criteria: * Hgb level of \< 9 g/dL at Screening * Symptomatic intradialytic hypotension requiring medical intervention (ultrafiltration turned off, bolus of fluid) in at least two treatments during the Run-In period defined as: 1. Persistent pre-dialysis sitting SBP \< 100 mmHg despite medical therapy, 2. Nadir intradialytic Systolic Blood Pressure (SBP) \< 90 mmHg, if Subject's pre-HD SBP \< 160 mmHg 3. Nadir intradialytic SBP \< 100 mmHg if Subject's pre-HD SBP ≥ 160 mmHg * Documented history of non-adherence to dialysis therapy that would prevent successful completion of the study * Participant had an average ultrafiltration rate \> 13 mL/kg/hour during the last 2 weeks prior to Screening, per medical records. * Had a significant cardiovascular adverse event within the last 90 days prior to Screening.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease end stage renal failure kidney disorder kidney failure

As listed by the trial registrant

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

End-stage kidney disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Nephrology Associates of Knoxville

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • New York Kidney Hypertension Medicine

    RECRUITING

    New Hyde Park, New York, 11040, United States

  • North America Research Institute

    RECRUITING

    San Dimas, California, 91773, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98104, United States

  • aQua Research Institute, LLC

    RECRUITING

    Houston, Texas, 77058, United States

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