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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-Center | Placebo Comparator | Staff administered treatments in-center using the device |
|
| In-Home | Experimental | Patient administered treatments in-home using the device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tablo Hemodialysis System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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:
| 8 weeks per period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outset Medical | San Jose | California | 95112 | United States |
A run-in period of 1 week (4 hemodialysis treatments) was required on the Tablo Hemodialysis System prior to the first period.
Patients were enrolled at 8 dialysis centers throughout the U.S.
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| ID | Title | Description |
|---|---|---|
| FG000 | In-Center Dialysis, Then In-Home Dialysis | Subjects first entered the In-Center period of the trial before transitioning to the In-Home period. Dialysis treatments were based on physician prescription (clearance and volume targets) and included the following schedules:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| In-Center Period |
| |||||||||||||
| Transition Period |
| |||||||||||||
| In-Home Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intention-To-Treat (ITT) Population | The ITT population was defined as all participants who were enrolled and fulfilled inclusion criteria. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention-to-treat (ITT) population with no imputation of missing values. | Posted | Mean | Standard Deviation | Weekly Standardized Kt/V | 8 weeks per period |
|
Adverse event data was collected during the following time periods: In-Center Period: 8 weeks Transition Period: 4 weeks In-Home Period: 8 weeks
All AEs were required to be reported in the trial and were assessed through participant questionnaires, investigator assessments and laboratory testing.
AEs were reviewed by an independent Clinical Events Committee (CEC) and adjudicated into two categories:
Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | In-Center | Staff administered hemodialysis treatments for participants 4 times per week for 8 weeks In-Center using the Tablo system |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated to Tablo System | Investigations | MedDRA 20.0 | Systematic Assessment | Adverse events deemed unrelated to Tablo Hemodialysis System |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Outset Medical, Inc | (669) 231-8200 | clinical@outsetmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 9, 2020 | Apr 7, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2019 | Apr 7, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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Subjects will be enrolled in the trial for approximately 21 weeks according to the following schedule:
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| 8 weeks per period |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Vascular Access Type | Count of Participants | Participants |
|
Participants administered hemodialysis treatments In-Home using the Tablo system |
|
|
| Primary | 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:
| Safety Population | Posted | Number | Adverse Events | 8 weeks per period |
|
|
|
| Secondary | 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. | Intention-to-treat (ITT) population with no imputation of missing values. | Posted | Number | Percentage of Dialysis Treatments | 8 weeks per period |
|
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| 14 |
| 30 |
| EG001 | Transition Period | Staff and participant administered hemodialysis treatments using the Tablo system | 1 | 30 | 2 | 30 | 6 | 30 |
| EG002 | In-Home | Participants administered hemodialysis treatments In-Home using the Tablo system | 0 | 28 | 2 | 28 | 10 | 28 |
| Vascular Access Site Complication | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Fluid Overload | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
|
| Blood Loss from Dialyzer & Lines | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |