End Stage Renal DiseaseHOMENCT04526301
Home With TablO outcoMEs (HOME) Registry
An observational study of End Stage Renal Disease, run by Outset Medical at 10 sites in United States.
Trial summary
Prospective, multicenter, single arm, post-market study to evaluate real world clinical outcomes in ESRD patients receiving in-home dialysis on the Tablo Hemodialysis System. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Tablo Hemodialysis System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 10 sitesUnited States
- Study dates
- 14 Jul 2020to 31 Jul 2024
- How long will I take part?
- 1 Year
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with end stage renal disease (ESRD) who are on, or planning to be on, maintenance hemodialysis.
Who may be able to join
- Participant (patient and/or care partner) is at least 15 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
- Participant weighs ≥ 34kg.
- Participant has end stage renal disease (ESRD) adequately treated by maintenance dialysis.
- Participant plans to start or has started home treatment (≤ 6 months) with the Tablo Hemodialysis System.
- Participant is willing and able to comply with the Protocol requirements and perform all site required treatments and clinical evaluations.
Who cannot join
- Participant and/or care partner is unable to read English or Spanish.
- Participant has a home environment that is deemed inappropriate for home dialysis.
- Participant and/or care partner is unable to successfully complete the Tablo training program
- Participant is pregnant or plans to become pregnant.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites, 8 recruiting
- Recruiting
St. Peter's Health
Helena, Montana, 59601
Alice Luehr
Robert LaClair, MD
- Recruiting
Dialysis Center of Lincoln
Lincoln, Nebraska, 68512
Corinne Morehead
Matt Glathar, MD
- Recruiting
Parker Jewish Institute
New Hyde Park, New York, 11040
Alana Doonacher
Sayed Ali, MD
- Recruiting
NYU Grossman School of Medicine
New York, New York, 10016
Paula Dutka
Naveed Masani, MD
- Recruiting
Rogosin Institute
New York, New York, 10021
Kimberly Davis
Frank Liu, MD
- Recruiting
Berkshire Medical Center
Pittsfield, Massachusetts, 01201
Tammy Bator, RN
David Henner, M.D.
- Recruiting
USRC Kidney Research
Plano, Texas, 75024
Stephanie Brillhart, MSCI
Geoff Block, MD
- Recruiting
Satellite Healthcare, Inc.
San Jose, California, 95128
Kshama Mehta
Wael Hussein, MD
- Withdrawn
University of Virginia
Staunton, Virginia, 24401
- Completed
Desert Cities Dialysis
Victorville, California, 92395
About this study
Prospective, multicenter, single arm, post-market study to evaluate real world clinical outcomes in ESRD patients receiving in-home dialysis on the Tablo Hemodialysis System.
- Conditions
- End Stage Renal Disease
- Being tested
- Tablo Hemodialysis System
- Keywords
- Tablo, Outset Medical, ESRD, Home Hemodialysis, HHD, ESKD
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablo Hemodialysis SystemDevice
Home hemodialysis treatments ~4 times a week.
| Study group | Role | What they receive |
|---|---|---|
| Tablo Hemodialysis System | Home dialysis treatment with the Tablo Hemodialysis System Receives: Device: Tablo Hemodialysis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Standardized Dialysis Adequacy
Weekly standardized dialysis adequacy (stdKt/V) measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. stdKt/V values of ≥ 2.1 are regarded as being adequate.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start14 Jul 2020
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal 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
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Outset Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526301
- Sponsor's protocol ID
- 2020-02
- Acronym
- HOME
- Status last verified
- Aug 2022
- First submitted
- 14 Aug 2020
- Last updated
- 23 Sep 2022
- Results posted
- 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 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home With TablO outcoMEs (HOME) Registry
- ClinicalTrials.gov ID
- NCT04526301
- Acronym / sponsor ID
- HOME / 2020-02
- Conditions
- End Stage Renal Disease
- Keywords
- Tablo, Outset Medical, ESRD, Home Hemodialysis, HHD, ESKD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Outset MedicalIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 25 Aug 2020 (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.
Prospective, multicenter, single arm, post-market study to evaluate real world clinical outcomes in ESRD patients receiving in-home dialysis on the Tablo Hemodialysis System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tablo Hemodialysis System | – | Device: Tablo Hemodialysis SystemHome dialysis treatment with the Tablo Hemodialysis System |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with end stage renal disease (ESRD) who are on, or planning to be on, maintenance hemodialysis.
Key inclusion criteria (5 listed)
- Participant (patient and/or care partner) is at least 15 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
- Participant weighs ≥ 34kg.
- Participant has end stage renal disease (ESRD) adequately treated by maintenance dialysis.
- Participant plans to start or has started home treatment (≤ 6 months) with the Tablo Hemodialysis System.
- Participant is willing and able to comply with the Protocol requirements and perform all site required treatments and clinical evaluations.
Key exclusion criteria (4 listed)
- Participant and/or care partner is unable to read English or Spanish.
- Participant has a home environment that is deemed inappropriate for home dialysis.
- Participant and/or care partner is unable to successfully complete the Tablo training program
- Participant is pregnant or plans to become pregnant.
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 |
|---|---|---|
| Tablo Hemodialysis SystemHome hemodialysis treatments ~4 times a week. | Device | Tablo Hemodialysis System |
Primary outcome
Weekly Standardized Dialysis Adequacy
Time frame: 12-months
Weekly standardized dialysis adequacy (stdKt/V) measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. stdKt/V values of ≥ 2.1 are regarded as being adequate.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease, run by Outset Medical at 10 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 5 inclusion and 4 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 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Contact Josh Schumacher ((669) 231-8200, ClinicalTeam@outsetmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly Standardized Dialysis Adequacy (time frame: 12-months). 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 23 Sep 2022.