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

AWAK Technologies Pte Ltd1 site in 1 country12 target enrollmentMarch 31, 2023

ConditionsChronic Kidney Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Kidney Diseases
Sponsor: AWAK Technologies Pte Ltd
Enrollment: 12
Locations: 1
Primary Endpoint: Proportion of completed therapies
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 31, 2023

End Date

July 29, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AWAK Technologies Pte Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent to participate in the study.
•Male or female ≥22 years of age.
•Treated with PD for at least 3 months before Screening.
•Has weekly Kt/Vurea (renal + peritoneal) ≥1.7
•No acute peritonitis, catheter infection, exit site, or subcutaneous tunnel infection within 3 months before Screening.

Exclusion Criteria

•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
•Recent (within the previous 6 months) history of major cardiovascular events (e.g., stroke, acute myocardial infarction).
•Diagnosed with New York Heart Association (NYHA) Class III or Class IV heart failure.
•Poorly controlled diabetes mellitus as defined by hemoglobin A1c \>9.0% during Screening
•Subject has a current abdominal hernia.
•Subject has an active infection requiring systemic antibiotics or antifungal therapy.
•Active infection of hepatitis B and C, or HIV infection at any time.

Outcomes

Primary Outcomes

Proportion of completed therapies

Time Frame: 7 days

Secondary Outcomes

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)