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

Primary Purpose

Chronic Kidney Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
AWAK PD
Sponsored by
AWAK Technologies Pte Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Peritoneal dialysis, Wearable medical device, Home-based therapy

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Singapore General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AWAK PD

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of completed therapies

Secondary Outcome Measures

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

Full Information

First Posted
March 30, 2023
Last Updated
April 12, 2023
Sponsor
AWAK Technologies Pte Ltd
Collaborators
Singapore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05827588
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AWAK Technologies Pte Ltd
Collaborators
Singapore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Peritoneal dialysis, Wearable medical device, Home-based therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AWAK PD
Arm Type
Experimental
Arm Description
Wearable/Ultra-portable peritoneal dialysis device for home-use
Intervention Type
Device
Intervention Name(s)
AWAK PD
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of completed therapies
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Proportion of subjects maintaining body weight within ±5% of the subject's target weight
Time Frame
7 days
Title
Change in serum levels of markers of uremia (urea and creatinine)
Time Frame
7 days
Title
Proportion of subjects maintaining serum sodium and potassium levels within normal clinical ranges
Time Frame
7 days
Title
Incidence of serious adverse events (SAEs), serious adverse device effects (SADEs), adverse events (AEs), adverse device effects (ADEs), and device deficiency events
Time Frame
7 days
Title
Incidence of peritonitis related to the use of AWAK PD
Time Frame
30 days
Title
Change in the incidence and severity of dialysis-related signs and symptoms based on responses on the PD Dialysis Symptoms Questionnaire
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
(65)63237543
Email
imu@singhealth.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjorie Foo
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
(65)63237543
Email
imu@singhealth.com.sg
First Name & Middle Initial & Last Name & Degree
Marjorie Foo

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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