Chronic Kidney Diseases
Conditions
Keywords
Peritoneal dialysis, Wearable medical device, Home-based therapy
Brief summary
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
Interventions
DEVICEAWAK PD
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
Sponsors
Singapore General Hospital
AWAK Technologies Pte Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of completed therapies | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Proportion of subjects maintaining body weight within ±5% of the subject's target weight | 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 |
| Incidence of serious adverse events (SAEs), serious adverse device effects (SADEs), adverse events (AEs), adverse device effects (ADEs), and device deficiency events | 7 days |
Countries
Singapore
Outcome results
None listed