Kidney DiseaseSCALE-PDNCT07059962
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
An observational study of Kidney Disease and Peritoneal Dialysis (PD), run by Bodyport Inc. at 7 sites in 2 countries.
Trial summary
To explore the use of the Bodyport Cardiac Scale in predicting worsening of events due to fluid overload in patients with kidney disease on peritoneal dialysis. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Kidney Disease, Peritoneal Dialysis (PD), End Stage Kidney Disease (ESRD)
- What is being tested?
- Bodyport Cardiac Scale
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 9 Sep 2025to Nov 2027
- Phase
- Observational
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males and females 21 years of age or older, with end stage kidney disease undergoing peritoneal dialysis.
Who may be able to join
- Age 21 years or older
- Able to speak and read English, or able to speak and read Spanish and has a caregiver or family member who speaks English and can provide assistance
- Able to stand on two bare feet unassisted
- Receiving automated peritoneal dialysis for the treatment of ESKD
- Followed on the Vantive Sharesource Remote Patient Management Platform
Who cannot join
- Undergoing or plan to undergo hemodialysis in the next 12 months
- Have a life expectancy of less than 12 months
- Are pregnant or plan to become pregnant during the next 12 months
- Weigh greater than 375 lbs
- Planned kidney transplant within the next 12 months
- Have an implanted neurostimulator system
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
Southeastern Clinical Research Institute
Augusta, Georgia, 30904
Meredith Prichard, 706-922-3005, mprichard@scri.care
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Alexis Stevenson, 312-503-3901, alexis.stevenson@northwestern.edu
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Dr. Kerri Cavanaugh, 615-936-7306, kerri.cavanaugh@vumc.org
- Recruiting
Desert Cities Dialysis
Victorville, California, 92395
Heberto Schramm, (760) 998 - 2060, hschramm@dcdialysis.com
Canada3 sites, 3 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Disha Sharma, 416-867-7460, Disha.Sharma@unityhealth.to
- Recruiting
St. Joseph's Health Centre
Toronto, Ontario, M6R 1B5
David Choi, 416-867-7460, Davidjeehoon.Choi@unityhealth.to
- Recruiting
Seven Oaks General Hospital
Winnipeg, Manitoba, R2V 3M3
Trang Nguyen, 1-204-632-3661, tnguyen31@sogh.mb.ca
About this study
Official title: Sensor-based Congestion Alert for Events in Peritoneal Dialysis (SCALE-PD)
To explore the use of the Bodyport Cardiac Scale in predicting worsening of events due to fluid overload in patients with kidney disease on peritoneal dialysis.
Read the detailed description
The objective of this study is to explore the utility of hemodynamic biomarkers measured by the Bodyport Cardiac Scale in predicting worsening events attributable to fluid overload among those with kidney disease on peritoneal dialysis. The study will explore individual biomarkers, as well as composite biomarker indices, such as the Congestion Index and a novel PD Index.
- Being tested
- Bodyport Cardiac Scale
- Keywords
- kidney disease, peritoneal dialysis, fluid overload, heart failure
- Medical subject headings
- Kidney Diseases, Kidney Failure, Chronic, Edema, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bodyport Cardiac ScaleDevice
The Bodyport Cardiac Scale captures several physiological signals, which are used to derive multiple biomarkers that reflect a user's hemodynamic and fluid status.
| Study group | Role | What they receive |
|---|---|---|
| PD Patients | Patients with kidney disease on peritoneal dialysis. Receives: Device: Bodyport Cardiac Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity Analysis
Sensitivity for predicting usable PDE > 0.40 and an alert rate of < 4.3 alerts per patient-year.
Measured: 1 year
Secondary outcomes (1)
Peritoneal Dialysis (PD) Events
Collection of approximately 40 usable PD Events for model development and validation. These events are defined as urgent, unscheduled clinic visits or emergency department visits or hospital admissions for worsening fluid overload and initiation or intensification of treatment for fluid overload or termination of treatment due to fluid related cause.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start9 Sep 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bodyport Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059962
- Sponsor's protocol ID
- CP-ScalePD-01
- Acronym
- SCALE-PD
- Status last verified
- Nov 2025
- First submitted
- 24 Jun 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No