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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-06

Study Completion Date

2027-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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End Stage Kidney Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Professional Care and At Home

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

Group Type EXPERIMENTAL

Moda-flx Hemodialysis System™

Intervention Type DEVICE

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

Interventions

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Moda-flx Hemodialysis System™

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No