Moda-flx Hemodialysis System for clinic and at-home use

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial enrolls adults with end-stage kidney disease on stable maintenance dialysis and a functioning vascular access to test the Moda-flx Hemodialysis System in both professional centers and home settings. Participants and their care partners will undergo a training period and must complete a skills and comprehension assessment before performing home treatments, with initial treatments also conducted under professional supervision during a run-in period. Key outcomes include dialysis adequacy, device-related adverse events, and intradialytic events such as hypotension, monitored during follow-up visits at study sites. Screening excludes patients with hemoglobin <9 g/dL or recurrent symptomatic intradialytic hypotension and requires stable vascular access with blood flow ≥300 mL/min.

Why it matters

Who can join: the full rules

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.

Where it's running

• North America Research Institute
  San Dimas, California, United States Recruiting
• New York Kidney Hypertension Medicine
  New Hyde Park, New York, United States Recruiting
• Nephrology Associates of Knoxville
  Knoxville, Tennessee, United States Recruiting
• aQua Research Institute, LLC
  Houston, Texas, United States Recruiting
• University of Washington
  Seattle, Washington, United States Recruiting

Study contacts

• Study coordinator: Michael Gastauer
• Email: HomeTrial@Diality.com
• Phone: 949-916-5851

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.