Chronic Kidney DiseasesNCT05827588
Late Feasibility Study to Evaluate Safety and Efficacy of AWAK PD Device in Subjects With ESKD.
A study testing AWAK PD in people with Chronic Kidney Diseases, run by AWAK Technologies Pte Ltd at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- AWAK PD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSingapore
- Study dates
- 31 Mar 2023to 29 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Chronic Kidney Diseases
- Being tested
- AWAK PD
- Keywords
- Peritoneal dialysis, Wearable medical device, Home-based therapy
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| AWAK PD | Experimental | Wearable/Ultra-portable peritoneal dialysis device for home-use Receives: Device: AWAK PD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of completed therapies
Measured: 7 days
Secondary outcomes (6)
Proportion of subjects maintaining body weight within ±5% of the subject's target weight
Measured: 7 days
Change in serum levels of markers of uremia (urea and creatinine)
Measured: 7 days
Proportion of subjects maintaining serum sodium and potassium levels within normal clinical ranges
Measured: 7 days
Incidence of serious adverse events (SAEs), serious adverse device effects (SADEs), adverse events (AEs), adverse device effects (ADEs), and device deficiency events
Measured: 7 days
Incidence of peritonitis related to the use of AWAK PD
Measured: 30 days
Change in the incidence and severity of dialysis-related signs and symptoms based on responses on the PD Dialysis Symptoms Questionnaire
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start31 Mar 2023
- Primary completion10 Mar 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AWAK Technologies Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Singapore General Hospital
- Responsible party
- Sponsor
- Investigators
- Marjorie Foo, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827588
- Sponsor's protocol ID
- SG-CLI-DOC-445
- Status last verified
- Jul 2024
- First submitted
- 30 Mar 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05827588
- Acronym / sponsor ID
- SG-CLI-DOC-445
- Conditions
- Chronic Kidney Diseases
- Keywords
- Peritoneal dialysis, Wearable medical device, Home-based therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AWAK Technologies Pte LtdIndustry (pharma, biotech, devices)
- Collaborators
- Singapore General Hospital
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AWAK PD | Experimental | Device: AWAK PDWearable/Ultra-portable peritoneal dialysis device for home-use |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AWAK PDDaily 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 | Device | AWAK PD |
Primary outcome
Proportion of completed therapies
Time frame: 7 days
6 secondary outcomes
Proportion of subjects maintaining body weight within ±5% of the subject's target weight
Time frame: 7 days
Change in serum levels of markers of uremia (urea and creatinine)
Time frame: 7 days
Proportion of subjects maintaining serum sodium and potassium levels within normal clinical ranges
Time frame: 7 days
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
Incidence of peritonitis related to the use of AWAK PD
Time frame: 30 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjorie Foo principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AWAK PD in people with Chronic Kidney Diseases, run by AWAK Technologies Pte Ltd at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of completed therapies (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.