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

Recruiting now · Not applicable

Conditions studied: End Stage Kidney Disease

In brief

The purpose of this study is to evaluate the safety and efficacy of the Moda-flx Hemodialysis System™ when used Under Professional Care Settings by trained individuals and At Home by trained Participants and Care Partners

Key facts

Study ID

NCT06613568

Run by

Diality Inc.

People needed

50

Starts

2025-10-06

Expected to finish

2027-09-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• Persistent pre-dialysis sitting SBP < 100 mmHg despite medical therapy,
• Nadir intradialytic Systolic Blood Pressure (SBP) < 90 mmHg, if Subject's pre-HD SBP < 160 mmHg
• 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 is running

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

Full record on ClinicalTrials.gov

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