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Moda-flx Hemodialysis System™ for End Stage Kidney Disease

This study is testing the Moda-flx Hemodialysis System™, a portable hemodialysis system, for people with End Stage Kidney Disease (ESKD). The goal is to see how safe and effective it is when used by trained healthcare professionals and also by trained patients and their care partners at home. Researchers will measure how well the dialysis works each week and track any side effects for up to 10 weeks per period. You may be able to join if you are between 18 and 80 years old, have ESKD, and are already receiving maintenance dialysis that is working well. The study is currently unclear on its recruitment status and plans to enroll 50 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes for up to 10 weeks per period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06613568

Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants

Recruiting
NAAges 18–80InterventionalTreatment
Diality Inc.
~50 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Moda-flx Hemodialysis System™

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Weekly Standardized Dialysis Adequacy
Measured over Up to 10 weeks per period
+1 more outcome measured

Conditions

End Stage Kidney Disease

Explore related trials

Chronic Kidney Disease, Stage 5

Where it's being run

5 sites across 5 states
California1
New York1
Tennessee1
Texas1
Washington1

Study leadership

  • Cynthia Silva, MD · STUDY_DIRECTOR · Diality Inc.

Who to contact

Michael Gastauer
[email protected]
949-916-5851
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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:
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.

What this trial measures

  • Weekly Standardized Dialysis AdequacyUp to 10 weeks per period

    Standardized weekly (stdKt/V) values as measured once every week during the Professional Care and At Home treatment settings

  • Adverse Event (AE) RateUp to 10 weeks per period

    The adverse event (AE) rate: defined as the number of Study Emergent AEs per 100 dialysis treatments occurring in the At Home period of the study, compared with those occurring during the Professional Care period.