Late Feasibility Study to Evaluate Safety and Efficacy of AWAK PD Device in Subjects With ESKD.
Study Details
Study Description
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:
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the success of AWAK PD therapies when used in a home-setting
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the safety and effectiveness of the AWAK PD system
Participants will:
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be titrated to find a suitable AWAK PD prescription
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be trained on how to use the AWAK PD system independently
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use the AWAK PD system at home for at least 7 days
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AWAK PD Wearable/Ultra-portable peritoneal dialysis device for home-use |
Device: AWAK 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
|
Outcome Measures
Primary Outcome Measures
- Proportion of completed therapies [7 days]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Written informed consent to participate in the study.
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Male or female ≥22 years of age.
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Treated with PD for at least 3 months before Screening.
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Has weekly Kt/Vurea (renal + peritoneal) ≥1.7
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No acute peritonitis, catheter infection, exit site, or subcutaneous tunnel infection within 3 months before Screening.
Exclusion Criteria:
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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
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Recent (within the previous 6 months) history of major cardiovascular events (e.g., stroke, acute myocardial infarction).
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Diagnosed with New York Heart Association (NYHA) Class III or Class IV heart failure.
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Poorly controlled diabetes mellitus as defined by hemoglobin A1c >9.0% during Screening
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Subject has a current abdominal hernia.
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Subject has an active infection requiring systemic antibiotics or antifungal therapy.
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Active infection of hepatitis B and C, or HIV infection at any time.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Singapore General Hospital | Singapore | Singapore |
Sponsors and Collaborators
- AWAK Technologies Pte Ltd
- Singapore General Hospital
Investigators
- Principal Investigator: Marjorie Foo, Singapore General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SG-CLI-DOC-445