Late Feasibility Study to Evaluate Safety and Efficacy of AWAK PD Device in Subjects With ESKD.

AWAK Technologies

Status: Completed

Conditions: Chronic Kidney Diseases

Treatments: Device: AWAK PD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05827588

SG-CLI-DOC-445

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

AWAK PD

Experimental group

Description:

Wearable/Ultra-portable peritoneal dialysis device for home-use

Treatment:

Device: AWAK PD