End Stage Renal DiseaseTABLONCT02460263

The EvAluation of TaBlo In-CLinic and In-HOme

A study testing Tablo Hemodialysis System in people with End Stage Renal Disease, run by Outset Medical at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center by trained individuals and In-Home by trained Subjects. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: End Stage Renal Disease
What is being tested?: Tablo Hemodialysis System
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Dec 2015to May 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has end stage renal disease (ESRD) adequately treated by maintenance dialysis achieving a Kt/V ≥ 1.2 and has been deemed stable for at least three months by his/her treating nephrologist.
Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min.

Who cannot join

Life expectancy less than 12 months from first study procedure.
Subject has had a recent major cardiovascular adverse event within the last 3 months.
Subject has New York Class III or IV Congestive Heart Failure, or ejection fraction less than 30%.
Subject with fluid overload due to intractable ascites secondary to liver cirrhosis.
Subject has uncontrolled blood pressure.
Subject is intolerant to heparin.

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Subject is seroreactive for Hepatitis B Surface Antigen.
Subject has an active, life-threatening, rheumatologic disease.
Subject has a history of adverse reactions to dialyzer membrane material.
Subject is expected to receive an organ transplant during the course of the study.
Subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

Outset Medical
San Jose, California, 95112

Other trials in United States

About this study

Official title: A Prospective Multicenter, Open Label, Non-Randomized, Cross-Over Study Evaluating the Use of the Tablo Hemodialysis System In-Center and In-Home by Subjects With End Stage Renal Disease (ESRD) Who Are on Stable Dialysis Regimens

The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center by trained individuals and In-Home by trained Subjects.

Conditions: End Stage Renal Disease
Being tested: Tablo Hemodialysis System
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

Study groups in NCT02460263
Study group	Role	What they receive
In-Center	Placebo comparator	Staff administered treatments in-center using the device Receives: Device: Tablo Hemodialysis System
In-Home	Experimental	Patient administered treatments in-home using the device 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) was 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: 8 weeks per period
Incidence of Pre-Specified Adverse Events
All adverse events (AEs) observed in the trial were reviewed by an independent Clinical Events Committee (CEC). AEs adjudicated into the following pre-specified categories were included in the outcome measure:
1. Serious Adverse Event
2. Allergic Reaction: to dialyzer, blood tubing or chemical disinfectant.
3. Blood Loss: that leads to death, transfusion or fluid resuscitation with greater than 1 liter of crystalloid IV fluids.
4. Hemolytic Reaction: due to disinfectant exposure, dialysate temperature, mechanical failure or other device related causes.
5. Infection: any infection related to catheter, its tunnel or exit site, AV fistula, or AV graft.
6. Intra-Dialysis Event: a significant clinical event such as loss of consciousness, cardiac arrest, or seizure caused by device failure.
7. Vascular Access Complications
8. Pyrogenic Reaction
Measured: 8 weeks per period

Secondary outcomes (1)

Ultrafiltration Rate Success
The Ultrafiltration (UF) rate was calculated using the following method:
UF rate = (Fluid Removal Goal + Rinse Back Volume) / Treatment Duration.
Where: Fluid Removal Goal = (Today's Weight - Prescribed Estimated Dry Weight)
And: Rinse Back Volume = The volume of saline, 300mL, returned to the patient at the end of treatment.
Each dialysis treatment was flagged as a success with respect to UF if the actual UF rate was within 10% of the prescribed UF rate. The mean (i.e., success proportion) and standard deviation were computed by treatment period across all subjects, where the denominator for the mean calculations was the total number of treatments in each treatment period for which the subjects contributed non-missing UF data.
Measured: 8 weeks per period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2015May 2019

First posted2 Jun 2015 (estimated)
Study startDec 2015
Primary completionMay 2019
Study completionMay 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Subjects will be enrolled in the trial for approximately 21 weeks according to the following schedule: * Run-in, In-Center - Subjects undergo study staff administered dialysis treatment 4 times/week for 1 week * Treatment Period 1, In-Center - Subjects undergo study staff administered dialysis treatment 4 times/week for 32 treatments (approximately 8 weeks) * In-Home Transition - Subjects undergo device training for the study, perform self-care dialysis 4 times/week for approximately 4 weeks, and are assessed for stability in the new care environment. * Treatment Period 2, In-Home - Subjects undergo self-care dialysis treatment 4 times/week for 32 treatments (approximately 8 weeks)
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02460263
Sponsor's protocol ID: 2014-01
Acronym: TABLO
Status last verified: Jun 2020
First submitted: 20 May 2015
Last updated: 1 Jul 2020
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Multicenter, Open Label, Non-Randomized, Cross-Over Study Evaluating the Use of the Tablo Hemodialysis System In-Center and In-Home by Subjects With End Stage Renal Disease (ESRD) Who Are on Stable Dialysis Regimens
ClinicalTrials.gov ID: NCT02460263
Acronym / sponsor ID: TABLO / 2014-01
Conditions: End Stage Renal Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Outset MedicalIndustry (pharma, biotech, devices)
Study start: Dec 2015
Primary completion: May 2019 (actual)
Study completion: May 2019 (actual)
First posted: 2 Jun 2015 (estimated)
Results: Posted 1 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center by trained individuals and In-Home by trained Subjects.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: Subjects will be enrolled in the trial for approximately 21 weeks according to the following schedule: * Run-in, In-Center - Subjects undergo study staff administered dialysis treatment 4 times/week for 1 week * Treatment Period 1, In-Center - Subjects undergo study staff administered dialysis treatment 4 times/week for 32 treatments (approximately 8 weeks) * In-Home Transition - Subjects undergo device training for the study, perform self-care dialysis 4 times/week for approximately 4 weeks, and are assessed for stability in the new care environment. * Treatment Period 2, In-Home - Subjects undergo self-care dialysis treatment 4 times/week for 32 treatments (approximately 8 weeks)

Arm	Type	Receives
In-Center	Placebo comparator	Device: Tablo Hemodialysis SystemStaff administered treatments in-center using the device
In-Home	Experimental	Device: Tablo Hemodialysis SystemPatient administered treatments in-home using the device

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subject has end stage renal disease (ESRD) adequately treated by maintenance dialysis achieving a Kt/V ≥ 1.2 and has been deemed stable for at least three months by his/her treating nephrologist.
Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min.

Key exclusion criteria (11 listed)

Life expectancy less than 12 months from first study procedure.
Subject has had a recent major cardiovascular adverse event within the last 3 months.
Subject has New York Class III or IV Congestive Heart Failure, or ejection fraction less than 30%.
Subject with fluid overload due to intractable ascites secondary to liver cirrhosis.
Subject has uncontrolled blood pressure.

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 System	Device	In-Center, In-Home

Primary outcome

Weekly Standardized Dialysis Adequacy
Time frame: 8 weeks per period
Weekly standardized dialysis adequacy (stdKt/V) was 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.
Incidence of Pre-Specified Adverse Events
Time frame: 8 weeks per period
All adverse events (AEs) observed in the trial were reviewed by an independent Clinical Events Committee (CEC). AEs adjudicated into the following pre-specified categories were included in the outcome measure: 1. Serious Adverse Event 2. Allergic Reaction: to dialyzer, blood tubing or chemical disinfectant. 3. Blood Loss: that leads to death, transfusion or fluid resuscitation with greater than 1 liter of crystalloid IV fluids. 4. Hemolytic Reaction: due to disinfectant exposure, dialysate temperature, mechanical failure or other device related causes. 5. Infection: any infection related to catheter, its tunnel or exit site, AV fistula, or AV graft. 6. Intra-Dialysis Event: a significant clinical event such as loss of consciousness, cardiac arrest, or seizure caused by device failure. 7. Vascular Access Complications 8. Pyrogenic Reaction

1 secondary outcome

Ultrafiltration Rate Success
Time frame: 8 weeks per period

Results and safety

Results posted to the registry on 1 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
In-Center Dialysis, Then In-Home Dialysis	30	30

Primary outcome: Weekly Standardized Dialysis Adequacy

Time frame: 8 weeks per period. Mean (Standard Deviation). Unit: Weekly Standardized Kt/V

Measure	In-Center n = 30	In-Home n = 28
Value	2.8 (0.3)	2.8 (0.3)

Population analysed: Intention-to-treat (ITT) population with no imputation of missing values.

Primary outcome: Incidence of Pre-Specified Adverse Events

Time frame: 8 weeks per period. Number. Unit: Adverse Events

Measure	In-Center n = 30	In-Home n = 28
Value	2	6

Population analysed: Safety Population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected during the following time periods: In-Center Period: 8 weeks Transition Period: 4 weeks In-Home Period: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
In-Center	1 of 30 (3.3%)	14 of 30 (46.7%)	0 of 30
Transition Period	2 of 30 (6.7%)	6 of 30 (20%)	1 of 30
In-Home	2 of 28 (7.1%)	10 of 28 (35.7%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
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RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tablo Hemodialysis System in people with End Stage Renal Disease, run by Outset Medical at 1 site 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 1 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Weekly Standardized Dialysis Adequacy (time frame: 8 weeks per period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02460263.

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 1 Jul 2020.