Trial Outcomes & Findings for The EvAluation of TaBlo In-CLinic and In-HOme (NCT NCT02460263)

Last Updated: 2020-07-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

8 weeks per period

Results posted on

2020-07-01

Participant Flow

Patients were enrolled at 8 dialysis centers throughout the U.S.

A run-in period of 1 week (4 hemodialysis treatments) was required on the Tablo Hemodialysis System prior to the first period.

Participant milestones

Participant milestones
Measure	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: * Treatment Period 1, In-Center - Subjects received study staff administered dialysis treatment 4 times/week for 32 treatments (approximately 8 weeks) * In-Home Transition- Subjects received device training and performed self-care dialysis 4 times/week for approximately 4 weeks, and were assessed for stability in the new care environment. * Treatment Period 2, In-Home - Subjects received self-care dialysis treatment 4 times/week for 32 treatments (approximately 8 weeks)
In-Center Period STARTED	30
In-Center Period COMPLETED	30
In-Center Period NOT COMPLETED	0
Transition Period STARTED	30
Transition Period COMPLETED	28
Transition Period NOT COMPLETED	2
In-Home Period STARTED	28
In-Home Period COMPLETED	28
In-Home Period NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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: * Treatment Period 1, In-Center - Subjects received study staff administered dialysis treatment 4 times/week for 32 treatments (approximately 8 weeks) * In-Home Transition- Subjects received device training and performed self-care dialysis 4 times/week for approximately 4 weeks, and were assessed for stability in the new care environment. * Treatment Period 2, In-Home - Subjects received self-care dialysis treatment 4 times/week for 32 treatments (approximately 8 weeks)
Transition Period Withdrawal by Subject	1
Transition Period Death	1

Baseline Characteristics

The EvAluation of TaBlo In-CLinic and In-HOme

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intention-To-Treat (ITT) Population n=30 Participants The ITT population was defined as all participants who were enrolled and fulfilled inclusion criteria.
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants
Vascular Access Type Fistula	23 Participants n=5 Participants
Vascular Access Type Catheter	4 Participants n=5 Participants
Vascular Access Type Graft	3 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks per period

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

Outcome measures

Outcome measures
Measure	In-Center n=30 Participants Staff administered hemodialysis treatments for participants 4 times per week for 8 weeks In-Center using the Tablo system	In-Home n=28 Participants Participants administered hemodialysis treatments In-Home using the Tablo system
Weekly Standardized Dialysis Adequacy	2.8 Weekly Standardized Kt/V Standard Deviation 0.3	2.8 Weekly Standardized Kt/V Standard Deviation 0.3

PRIMARY outcome

Timeframe: 8 weeks per period

Population: Safety Population

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

Outcome measures

Outcome measures
Measure	In-Center n=30 Participants Staff administered hemodialysis treatments for participants 4 times per week for 8 weeks In-Center using the Tablo system	In-Home n=28 Participants Participants administered hemodialysis treatments In-Home using the Tablo system
Incidence of Pre-Specified Adverse Events	2 Adverse Events	6 Adverse Events

SECONDARY outcome

Timeframe: 8 weeks per period

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

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.

Outcome measures

Outcome measures
Measure	In-Center n=30 Participants Staff administered hemodialysis treatments for participants 4 times per week for 8 weeks In-Center using the Tablo system	In-Home n=28 Participants Participants administered hemodialysis treatments In-Home using the Tablo system
Ultrafiltration Rate Success	94 Percentage of Dialysis Treatments	94 Percentage of Dialysis Treatments

Adverse Events

In-Center

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Transition Period

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

In-Home

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	In-Center n=30 participants at risk Staff administered hemodialysis treatments for participants 4 times per week for 8 weeks In-Center using the Tablo system	Transition Period n=30 participants at risk Staff and participant administered hemodialysis treatments using the Tablo system	In-Home n=28 participants at risk Participants administered hemodialysis treatments In-Home using the Tablo system
Injury, poisoning and procedural complications Fall	3.3% 1/30 • Number of events 1 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).	0.00% 0/30 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).	3.6% 1/28 • Number of events 2 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).
Skin and subcutaneous tissue disorders Vascular Access Site Complication	0.00% 0/30 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).	3.3% 1/30 • Number of events 1 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).	0.00% 0/28 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).
Cardiac disorders Cardiac Arrest	0.00% 0/30 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).	3.3% 1/30 • Number of events 1 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).	0.00% 0/28 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).
Injury, poisoning and procedural complications Fluid Overload	0.00% 0/30 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).	0.00% 0/30 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).	3.6% 1/28 • Number of events 1 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).

Other adverse events

Other adverse events
Measure	In-Center n=30 participants at risk Staff administered hemodialysis treatments for participants 4 times per week for 8 weeks In-Center using the Tablo system	Transition Period n=30 participants at risk Staff and participant administered hemodialysis treatments using the Tablo system	In-Home n=28 participants at risk Participants administered hemodialysis treatments In-Home using the Tablo system
Investigations Unrelated to Tablo System	43.3% 13/30 • Number of events 16 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).	20.0% 6/30 • Number of events 9 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).	32.1% 9/28 • Number of events 14 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).
Injury, poisoning and procedural complications Blood Loss from Dialyzer & Lines	3.3% 1/30 • Number of events 1 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).	0.00% 0/30 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).	7.1% 2/28 • Number of events 3 • 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: 1. Pre-specified AEs (e.g., SAEs and/or treatment-related events) 2. Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).

Additional Information

Clinical Operations

Outset Medical, Inc

Phone: (669) 231-8200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place