Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants
- Conditions
- End Stage Kidney Disease
- Interventions
- Device: Moda-flx Hemodialysis System™
- Registration Number
- NCT06613568
- Lead Sponsor
- Diality Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Are between 18 and 75 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 Run-In Period
- In the opinion of the Investigator, 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 the Run-In Period
- In the opinion of the Investigator, can successfully complete a Skills Assessment with a Care Partner prior to the completion of the Training Period
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Professional Care and At Home Moda-flx Hemodialysis System™ Participants will receive dialysis therapy using the Moda-Flx Hemodialysis System™ in a Professional Care setting and At-Home setting
- Primary Outcome Measures
Name Time Method Weekly Standardized Dialysis Adequacy Up to 16 weeks Standardized weekly (stdKt/V) values as measured once every week during the Professional Care and At Home treatment settings
Adverse Event Rate Up to 16 weeks The adverse event (AE) rate: defined as the number of AEs per 100 dialysis intervals occurring in the At Home period of the study, compared with those occurring during the Professional Care period
- Secondary Outcome Measures
Name Time Method Goal Ultrafiltration Volume Up to 22 weeks Compliance with fluid removal goals that are defined as:
The Goal ultrafiltration volume as reported by the device (measured as a total volume over the whole duration of the treatment) will be within ±10 percent of the weighed ultrafiltration volume.Incidence of Pre-Specified Adverse Events Up to 22 weeks The total number of Study-Emergent AEs and SAEs (Serious Adverse Events) compared across study periods as well as for each of 3 Subgroups of the Study-Emergent AEs, including Pre-Specified (Anticipated) AEs, Unanticipated (not Pre-Specified) AEs, and Device-Related AEs. Under this analysis, Pre-Specified AEs will be comprised of any of the following:
1. A composite of:
* Serious Adverse Event
* Allergic Reaction
* Blood Loss
* Hemolytic Reaction
* Infection
* Intradialytic Event
* Vascular Access Complication
* Pyrogenic Reaction
2. Summary statistics to be displayed for the above individual components across both study periods