Clinical trial NCT05827588: Late Feasibility Study to Evaluate Safety and Efficacy of AWAK PD Device in Subjects With ESKD.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Peritoneal dialysis
Wearable medical device
Home-based therapy
Lead sponsor: AWAK Technologies Pte Ltd
Sponsor class: INDUSTRY
Collaborators: name: Singapore General Hospital
First posted: 2023-04-25
Enrollment: 12
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of completed therapies
timeFrame: 7 days
Secondary outcomes:
measure: Proportion of subjects maintaining body weight within ±5% of the subject's target weight
timeFrame: 7 days
measure: Change in serum levels of markers of uremia (urea and creatinine)
timeFrame: 7 days
measure: Proportion of subjects maintaining serum sodium and potassium levels within normal clinical ranges
timeFrame: 7 days
measure: Incidence of serious adverse events (SAEs), serious adverse device effects (SADEs), adverse events (AEs), adverse device effects (ADEs), and device deficiency events
timeFrame: 7 days
measure: Incidence of peritonitis related to the use of AWAK PD
timeFrame: 30 days
measure: Change in the incidence and severity of dialysis-related signs and symptoms based on responses on the PD Dialysis Symptoms Questionnaire
timeFrame: 30 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Marjorie Foo
role: PRINCIPAL_INVESTIGATOR
References: