Skip to main content
OpenTrials
Completed

NCT Number: NCT05827588

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore General Hospital

Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AWAK PD

Device

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 outcomes

  1. Proportion of completed therapies

    Time frame: 7 days

Secondary outcomes

  1. Proportion of subjects maintaining body weight within ±5% of the subject's target weight

    Time frame: 7 days

  2. Change in serum levels of markers of uremia (urea and creatinine)

    Time frame: 7 days

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

    Time frame: 7 days

  4. 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

  5. Incidence of peritonitis related to the use of AWAK PD

    Time frame: 30 days

  6. 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

Sponsors and collaborators

Lead sponsor

AWAK Technologies Pte Ltd

Industry

Collaborators

  • Singapore General Hospital

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 25, 2023
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.