Overview

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

Eligibility

Inclusion Criteria:

1. Written informed consent to participate in the study.
2. Male or female ≥22 years of age.
3. Treated with PD for at least 3 months before Screening.
4. Has weekly Kt/Vurea (renal + peritoneal) ≥1.7
5. No acute peritonitis, catheter infection, exit site, or subcutaneous tunnel infection within 3 months before Screening.

Exclusion Criteria:

1. 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
2. Recent (within the previous 6 months) history of major cardiovascular events (e.g., stroke, acute myocardial infarction).
3. Diagnosed with New York Heart Association (NYHA) Class III or Class IV heart failure.
4. Poorly controlled diabetes mellitus as defined by hemoglobin A1c >9.0% during Screening
5. Subject has a current abdominal hernia.
6. Subject has an active infection requiring systemic antibiotics or antifungal therapy.
7. Active infection of hepatitis B and C, or HIV infection at any time.