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

Chronic Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05827588
• Other study ID #: SG-CLI-DOC-445
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 31, 2023
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: AWAK Technologies Pte Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: May 2024
• Est. primary completion date: March 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
AWAK Technologies Pte Ltd	Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of completed therapies		7 days
Secondary	Proportion of subjects maintaining body weight within ±5% of the subject's target weight		7 days
Secondary	Change in serum levels of markers of uremia (urea and creatinine)		7 days
Secondary	Proportion of subjects maintaining serum sodium and potassium levels within normal clinical ranges		7 days
Secondary	Incidence of serious adverse events (SAEs), serious adverse device effects (SADEs), adverse events (AEs), adverse device effects (ADEs), and device deficiency events		7 days
Secondary	Incidence of peritonitis related to the use of AWAK PD		30 days
Secondary	Change in the incidence and severity of dialysis-related signs and symptoms based on responses on the PD Dialysis Symptoms Questionnaire		30 days