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

Not Applicable

Completed

• Conditions: Chronic Kidney Diseases
• Interventions: Device: AWAK PD

• Registration Number: NCT05827588
• Lead Sponsor: AWAK Technologies Pte Ltd

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-30
• Study Start: 2023-03-31
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-25
• Primary Completion: 2024-03-10
• Status Verified: 2024-07
• Study Completion: 2024-07-29
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AWAK PD	AWAK PD	Wearable/Ultra-portable peritoneal dialysis device for home-use

Primary Outcome Measures

Name	Time	Method
Proportion of completed therapies	7 days

Secondary Outcome Measures

Name	Time	Method
Incidence of peritonitis related to the use of AWAK PD	30 days
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
Incidence of serious adverse events (SAEs), serious adverse device effects (SADEs), adverse events (AEs), adverse device effects (ADEs), and device deficiency events	7 days
Proportion of subjects maintaining serum sodium and potassium levels within normal clinical ranges	7 days
Change in the incidence and severity of dialysis-related signs and symptoms based on responses on the PD Dialysis Symptoms Questionnaire	30 days

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore