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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor-based Congestion Alert for Events in Peritoneal Dialysis (SCALE-PD)
- ClinicalTrials.gov ID
- NCT07059962
- Acronym / sponsor ID
- SCALE-PD / CP-ScalePD-01
- Keywords
- kidney disease, peritoneal dialysis, fluid overload, heart failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Bodyport Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 11 Jul 2025 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD Patients | – | Device: Bodyport Cardiac ScalePatients with kidney disease on peritoneal dialysis. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females 21 years of age or older, with end stage kidney disease undergoing peritoneal dialysis.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Bodyport Cardiac ScaleThe Bodyport Cardiac Scale captures several physiological signals, which are used to derive multiple biomarkers that reflect a user's hemodynamic and fluid status. | Device | PD Patients |
Primary outcome
Sensitivity Analysis
Time frame: 1 year
Sensitivity for predicting usable PDE > 0.40 and an alert rate of < 4.3 alerts per patient-year.
1 secondary outcome
Peritoneal Dialysis (PD) Events
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Kidney Disease
Active, not recruitingObservational study
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
Atypical Hemolytic Uremic Syndrome(aHUS)
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 3
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruitingPhase 3
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v7
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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease and Peritoneal Dialysis (PD), run by Bodyport Inc. at 7 sites in 2 countries.
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 6 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corey Centen (415-990-5415, corey@bodyport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity Analysis (time frame: 1 year). 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 22 Oct 2026.