Late Feasibility Study to Evaluate Safety and Efficacy of AWAK PD Device in Subjects With ESKD.
Chronic Kidney Diseases
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Peritoneal dialysis, Wearable medical device, Home-based therapy
Eligibility Criteria
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.
Sites / Locations
- Singapore General HospitalRecruiting
Arms of the Study
Arm 1
Experimental
AWAK PD
Wearable/Ultra-portable peritoneal dialysis device for home-use