Late Feasibility Study to Evaluate Safety and Efficacy of AWAK PD Device in Subjects With ESKD.

Study Overview
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Brief Summary
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The goal of this late feasibility clinical trial is to evaluate the safety and effectiveness of the Automated Wearable Artificial Kidney (AWAK) peritoneal dialysis (PD) device in subjects with end-stage kidney disease. The main questions it aims to answer are: the success of AWAK PD therapies when used in a home-setting the safety and effectiveness of the AWAK PD system Participants will: be titrated to find a suitable AWAK PD prescription be trained on how to use the AWAK PD system independently use the AWAK PD system at home for at least 7 days

Official Title
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A Prospective, Single-arm Study to Evaluate the Feasibility of Automated Wearable Artificial Kidney Peritoneal Dialysis (AWAK PD) in Subjects With End-Stage Kidney Disease

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Device: AWAK PD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent to participate in the study. Male or female ≥22 years of age. Treated with PD for at least 3 months before Screening. Has weekly Kt/Vurea (renal + peritoneal) ≥1.7 No acute peritonitis, catheter infection, exit site, or subcutaneous tunnel infection within 3 months before Screening. Exclusion Criteria: Severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good investigation candidate Recent (within the previous 6 months) history of major cardiovascular events (e.g., stroke, acute myocardial infarction). Diagnosed with New York Heart Association (NYHA) Class III or Class IV heart failure. Poorly controlled diabetes mellitus as defined by hemoglobin A1c >9.0% during Screening Subject has a current abdominal hernia. Subject has an active infection requiring systemic antibiotics or antifungal therapy. Active infection of hepatitis B and C, or HIV infection at any time.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AWAK PD<br>Wearable/Ultra-portable peritoneal dialysis device for home-use | Device: AWAK PD<br>* Daily 7- or 9-hour therapy (with or without a last fill) that is a form of automated peritoneal dialysis being done by subjects who are already on daily PD therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of completed therapies |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects maintaining body weight within ±5% of the subject's target weight |  | 7 days | 
| Change in serum levels of markers of uremia (urea and creatinine) |  | 7 days | 
| Proportion of subjects maintaining serum sodium and potassium levels within normal clinical ranges |  | 7 days | 
| Incidence of serious adverse events (SAEs), serious adverse device effects (SADEs), adverse events (AEs), adverse device effects (ADEs), and device deficiency events |  | 7 days | 
| Incidence of peritonitis related to the use of AWAK PD |  | 30 days | 
| Change in the incidence and severity of dialysis-related signs and symptoms based on responses on the PD Dialysis Symptoms Questionnaire |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal dialysis, Wearable medical device, Home-based therapy