Kidney Failure, ChronicNCT05381961
Observational Study of BIS in Hemodialysis Patients
An observational study of Kidney Failure, Chronic and Renal Failure Chronic, run by ImpediMed Limited at 2 sites in United States.
Trial summary
This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Renal Failure Chronic, Hemodialysis
- What is being tested?
- Bioimpedance spectroscopy (BIS) measurement, SOZO device
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Apr 2022to Sep 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (aged 18+ years) with end-stage renal disease, are known to a study investigator, and undergo hemodialysis 3-times per week at an outpatient dialysis unit.
Who may be able to join
- Age >=18 years of age;
- End-stage renal disease with a GFR <15 mL/min/1.73m^2 and dialysis dependent requiring 3-times weekly dialysis;
- Able and willing to remove shoes and stand on SOZO for BIS measurements;
- Able to provide written informed consent and authorization to use and disclose health information.
Who cannot join
- Is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion;
- Has a clinical condition that would not allow them to complete the study;
- Is pregnant or planning to become pregnant; women of childbearing potential (or premenopausal) must be on 2 forms of contraception;
- Is lactating;
- Has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator);
- Has an amputation of a limb/s resulting in them being unable to make contact with the SOZO electrodes (amputations of fingers and toes are not an exclusion);
- Patient determined by the attending physician unlikely to be compliant with study procedures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Balboa Research - Kearny Mesa
San Diego, California, 92111
Balboa Research - Rancho Bernardo
San Diego, California, 92127
About this study
Official title: Observational Study of Bioimpedance Spectroscopy (BIS) for Use in a Renal Population
This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis.
Read the detailed description
This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis. If changes in BIS parameters correlate with changes in fluid volume and patient symptoms, BIS may help provide a non-invasive way to estimate the amount of fluid to dialyze during a hemodialysis session. Data from this study may be used to inform the design of a future interventional trial of BIS use in hemodialysis patients.
- Conditions
- Kidney Failure, Chronic, Renal Failure Chronic, Hemodialysis
- Being tested
- Bioimpedance spectroscopy (BIS) measurement, SOZO device
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioimpedance spectroscopy (BIS) measurement, SOZO deviceDevice
All patients enrolled in this study will undergo BIS measurement before and after 12 hemodialysis sessions (pre-dialysis and post-dialysis BIS measurements for each session). Measurements are not provided to treating physicians and are not used to guide clinical decisions; i.e., BIS measurements are collected for observational purposes only.
| Study group | Role | What they receive |
|---|---|---|
| Stable hemodialysis regimen | Up to 50 patients on hemodialysis >6 months, with stable target/dry weight, and have not been hospitalized recently Receives: Device: Bioimpedance spectroscopy (BIS) measurement, SOZO device | |
| Unstable hemodialysis regimen | Up to 20 patients who have been on hemodialysis <6 months, or have unintended weight loss/gain, or have recently been hospitalized Receives: Device: Bioimpedance spectroscopy (BIS) measurement, SOZO device |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIS correlation with amount of fluid dialyzed
BIS-measured fluid change (volume) will be analyzed for correlation with the volume of fluid removed during hemodialysis as documented on dialysis treatment records.
Measured: 12 hemodialysis sessions (over 4 to 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start4 Apr 2022
- Primary completion8 Nov 2022
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImpediMed Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Institute of Renal Research, Frenova Renal Research
- Responsible party
- Sponsor
- Investigators
- Mark Boiskin, MD, Principal investigator, Balboa Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381961
- Sponsor's protocol ID
- IPD-ESRD-001
- Status last verified
- Sep 2023
- First submitted
- 11 May 2022
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Bioimpedance Spectroscopy (BIS) for Use in a Renal Population
- ClinicalTrials.gov ID
- NCT05381961
- Acronym / sponsor ID
- IPD-ESRD-001
- Conditions
- Kidney Failure, Chronic, Renal Failure Chronic, Hemodialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- ImpediMed LimitedIndustry (pharma, biotech, devices)
- Collaborators
- California Institute of Renal Research, Frenova Renal Research
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- Sep 2023 (estimated)
- First posted
- 19 May 2022 (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.
This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis.
Detailed description
This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis. If changes in BIS parameters correlate with changes in fluid volume and patient symptoms, BIS may help provide a non-invasive way to estimate the amount of fluid to dialyze during a hemodialysis session. Data from this study may be used to inform the design of a future interventional trial of BIS use in hemodialysis patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stable hemodialysis regimen | – | Device: Bioimpedance spectroscopy (BIS) measurement, SOZO deviceUp to 50 patients on hemodialysis >6 months, with stable target/dry weight, and have not been hospitalized recently |
| Unstable hemodialysis regimen | – | Device: Bioimpedance spectroscopy (BIS) measurement, SOZO deviceUp to 20 patients who have been on hemodialysis <6 months, or have unintended weight loss/gain, or have recently been hospitalized |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (aged 18+ years) with end-stage renal disease, are known to a study investigator, and undergo hemodialysis 3-times per week at an outpatient dialysis unit.
Key inclusion criteria (4 listed)
- Age >=18 years of age;
- End-stage renal disease with a GFR <15 mL/min/1.73m^2 and dialysis dependent requiring 3-times weekly dialysis;
- Able and willing to remove shoes and stand on SOZO for BIS measurements;
- Able to provide written informed consent and authorization to use and disclose health information.
Key exclusion criteria (7 listed)
- Is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion;
- Has a clinical condition that would not allow them to complete the study;
- Is pregnant or planning to become pregnant; women of childbearing potential (or premenopausal) must be on 2 forms of contraception;
- Is lactating;
- Has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator);
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 |
|---|---|---|
| Bioimpedance spectroscopy (BIS) measurement, SOZO deviceAll patients enrolled in this study will undergo BIS measurement before and after 12 hemodialysis sessions (pre-dialysis and post-dialysis BIS measurements for each session). Measurements are not provided to treating physicians and are not used to guide clinical decisions; i.e., BIS measurements are collected for observational purposes only. | Device | Stable hemodialysis regimen, Unstable hemodialysis regimen |
Primary outcome
BIS correlation with amount of fluid dialyzed
Time frame: 12 hemodialysis sessions (over 4 to 6 weeks)
BIS-measured fluid change (volume) will be analyzed for correlation with the volume of fluid removed during hemodialysis as documented on dialysis treatment records.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Mark Boiskin, MD principal investigator
Balboa Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic and Renal Failure Chronic, run by ImpediMed Limited at 2 sites in United States.
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 4 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
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?
BIS correlation with amount of fluid dialyzed (time frame: 12 hemodialysis sessions (over 4 to 6 weeks)). 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 28 Sep 2023.