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

NCT06613568 | Recruiting FDA Device

• 1 other identifier: DIA-HHD-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

End Stage Kidney Disease

Keywords

Renal Disease; Hemodialysis Complication; Kidney Diseases; Dialysis; Renal Dialysis; Hemodialysis, Home; Renal Insufficiency; Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (2)

• Weekly Standardized Dialysis Adequacy

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

  Up to 10 weeks per period

• Adverse Event (AE) Rate

  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.

  Up to 10 weeks per period

Secondary Outcomes (2)

• Goal Ultrafiltration Volume

  Up to 10 weeks per period

• Study Emergent Pre-Specified Adverse Events

  Up to 10 weeks per period

Study Arms (1)

Professional Care and At Home

EXPERIMENTAL

Participants will receive dialysis therapy using the Moda-Flx Hemodialysis System™ in a Professional Care setting and At Home setting

Device: Moda-flx Hemodialysis System™

Interventions

Moda-flx Hemodialysis System™ DEVICE

The Moda-flx Hemodialysis System™ is a portable hemodialysis system

Professional Care and At Home

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Diality Inc.: lead

Study Sites (4)

North America Research Institute

San Dimas, California, 91773, United States

RECRUITING

Nephrology Associates of Knoxville

Knoxville, Tennessee, 37920, United States

RECRUITING

aQua Research Institute, LLC

Houston, Texas, 77058, United States

RECRUITING

University of Washington

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Kidney Diseases; Renal Insufficiency

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cynthia Silva, MD

  Diality Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael Gastauer

CONTACT

949-916-5851; HomeTrial@Diality.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: October 6, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)