NCT05827588

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 31, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

12 months

First QC Date

March 30, 2023

Last Update Submit

July 30, 2024

Conditions

Chronic Kidney Diseases

Keywords

Peritoneal dialysisWearable medical deviceHome-based therapy

Outcome Measures

Primary Outcomes (1)

  • Proportion of completed therapies

    7 days

Secondary Outcomes (6)

  • 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

  • Proportion of subjects maintaining serum sodium and potassium levels within normal clinical ranges

    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

  • Incidence of peritonitis related to the use of AWAK PD

    30 days

  • +1 more secondary outcomes

Study Arms (1)

AWAK PD

EXPERIMENTAL

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

Device: AWAK PD

Interventions

AWAK PDDEVICE

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

AWAK PD

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marjorie Foo

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 25, 2023

Study Start

March 31, 2023

Primary Completion

March 10, 2024

Study Completion

July 29, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)