The EvAluation of TaBlo In-CLinic and In-HOme (TABLO)
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tablo Hemodialysis System
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Outset Medical
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
In-Center
In-Home
Arm Description
Staff administered treatments in-center using the device
Patient administered treatments in-home using the device
Outcomes
Primary Outcome Measures
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.
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:
Serious Adverse Event
Allergic Reaction: to dialyzer, blood tubing or chemical disinfectant.
Blood Loss: that leads to death, transfusion or fluid resuscitation with greater than 1 liter of crystalloid IV fluids.
Hemolytic Reaction: due to disinfectant exposure, dialysate temperature, mechanical failure or other device related causes.
Infection: any infection related to catheter, its tunnel or exit site, AV fistula, or AV graft.
Intra-Dialysis Event: a significant clinical event such as loss of consciousness, cardiac arrest, or seizure caused by device failure.
Vascular Access Complications
Pyrogenic Reaction
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02460263
Brief Title
The EvAluation of TaBlo In-CLinic and In-HOme
Acronym
TABLO
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Outset Medical
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
In-Center
Arm Type
Placebo Comparator
Arm Description
Staff administered treatments in-center using the device
Arm Title
In-Home
Arm Type
Experimental
Arm Description
Patient administered treatments in-home using the device
Intervention Type
Device
Intervention Name(s)
Tablo Hemodialysis System
Primary Outcome Measure Information:
Title
Weekly Standardized Dialysis Adequacy
Description
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.
Time Frame
8 weeks per period
Title
Incidence of Pre-Specified Adverse Events
Description
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:
Serious Adverse Event
Allergic Reaction: to dialyzer, blood tubing or chemical disinfectant.
Blood Loss: that leads to death, transfusion or fluid resuscitation with greater than 1 liter of crystalloid IV fluids.
Hemolytic Reaction: due to disinfectant exposure, dialysate temperature, mechanical failure or other device related causes.
Infection: any infection related to catheter, its tunnel or exit site, AV fistula, or AV graft.
Intra-Dialysis Event: a significant clinical event such as loss of consciousness, cardiac arrest, or seizure caused by device failure.
Vascular Access Complications
Pyrogenic Reaction
Time Frame
8 weeks per period
Secondary Outcome Measure Information:
Title
Ultrafiltration Rate Success
Description
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.
Time Frame
8 weeks per period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Facility Information:
Facility Name
Outset Medical
City
San Jose
State/Province
California
ZIP/Postal Code
95112
Country
United States
12. IPD Sharing Statement
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The EvAluation of TaBlo In-CLinic and In-HOme
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