RecruitingNot Applicable

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

United States50 participantsStarted 2025-10-06

Plain-language summary

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

Who can participate

Age range18 Years – 80 Years

SexALL

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Exclusion criteria

✕. 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

What they're measuring

Weekly Standardized Dialysis Adequacy

Timeframe: Up to 10 weeks per period

Adverse Event (AE) Rate

Timeframe: Up to 10 weeks per period

Trial details

NCT IDNCT06613568

SponsorDiality Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Michael Gastauer

949-916-5851 HomeTrial@Diality.com

View on ClinicalTrials.gov More End Stage Kidney Disease trials