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

Prospective, Non-Randomized, Multicenter, Open-Label Study Evaluating the Use of the Moda-flx Hemodialysis System™ Under Professional Care and At Home by Participants With End Stage Kidney Disease (ESKD) Who Are on Stable Dialysis Regimens

This trial will test whether the Moda-flx Hemodialysis System can be used safely and effectively by trained professionals in clinics and by trained patients and care partners at home for adults with end-stage kidney disease.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Diality Inc. (industry)
• Locations: 4 sites (San Dimas, California and 3 other locations)
• Trial ID: NCT06613568 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–80 years old with end-stage kidney disease on stable maintenance dialysis (spKt/V ≥1.2 or stdKt/V ≥2.1), a well-functioning vascular access (≥300 mL/min), and who can complete training with a care partner are the ideal candidates.

Not a fit: Patients with hemoglobin below 9 g/dL, recurrent symptomatic intradialytic hypotension, unstable vascular access, or inability to complete training or secure a care partner are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this device could expand safe home hemodialysis options, giving suitable patients more convenience and potentially better quality of life.

How similar studies have performed: Home hemodialysis programs and other portable dialysis systems have shown safety and benefits in prior research, but the Moda-flx system itself appears novel with limited published outcome data.

Eligibility criteria

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 this trial is running

San Dimas, California and 3 other locations

• North America Research Institute — San Dimas, California, 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

Conditions: End Stage Kidney Disease, Renal Disease, Hemodialysis Complication, Kidney Diseases, Dialysis, Renal Dialysis, Hemodialysis, Home, Renal Insufficiency