End Stage Kidney Disease
Conditions
Keywords
Renal Disease, Hemodialysis Complication, Kidney Diseases, Dialysis, Renal Dialysis, Hemodialysis, Home, Renal Insufficiency, Kidney Failure, Chronic
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
Interventions
DEVICEModa-flx Hemodialysis System™
The Moda-flx Hemodialysis System™ is a portable hemodialysis system
Sponsors
Diality Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Standardized Dialysis Adequacy | Up to 10 weeks per period | Standardized weekly (stdKt/V) values as measured once every week during the Professional Care and At Home treatment settings |
| Adverse Event (AE) Rate | Up to 10 weeks per period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Goal Ultrafiltration Volume | Up to 10 weeks per period | Compliance with fluid removal goals that are defined as: Ultrafiltration (net fluid removal), such that the recorded value from the Moda-flx Hemodialysis System™ is within ± 100 mL/h or ± 250 mL (whichever is less) of set point during the treatment, based on the UF prescription. |
| Study Emergent Pre-Specified Adverse Events | Up to 10 weeks per period | Study Emergent Pre-Specified Adverse Eventss, categorized by study period (Professional Care and At Home) severity, device relationship and procedure relationship. Study-emergent Pre-Specified AEs are those AEs with an onset on or after the date of first treatment during the Run-In Period, which 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 |
Countries
United States
Contacts
CONTACTMichael Gastauer
STUDY_DIRECTORCynthia Silva, MD
Diality Inc.
Outcome results
None listed