TABLO: The EvAluation of TaBlo In-CLinic and In-HOme

• Sponsor: Outset Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02460263
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 41
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease	Device: Tablo Hemodialysis System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention 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)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)
• Primary Purpose: Treatment
• 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 Start Date: Dec 1, 2015
• Actual Primary Completion Date: May 1, 2019
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: In-Center Staff administered treatments in-center using the device	Device: Tablo Hemodialysis System
Experimental: In-Home Patient administered treatments in-home using the device	Device: Tablo Hemodialysis System

Outcome Measures

Primary Outcome Measures

1. Weekly Standardized Dialysis Adequacy [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.

2. Incidence of Pre-Specified Adverse Events [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: 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

1. Ultrafiltration Rate Success [8 weeks per period]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Outset Medical	San Jose	California	United States	95112

Sponsors and Collaborators

• Outset Medical

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jan 9, 2020
• Statistical Analysis Plan - Apr 25, 2019

More Information

Publications

None provided.

• Responsible Party: Outset Medical
• ClinicalTrials.gov Identifier: NCT02460263
• Other Study ID Numbers: 2014-01
• First Posted: Jun 2, 2015
• Last Update Posted: Jul 1, 2020
• Last Verified: Jun 1, 2020

• Additional relevant MeSH terms: Kidney Diseases; Kidney Failure, Chronic

Study Results

Participant Flow

Recruitment Details	Patients were enrolled at 8 dialysis centers throughout the U.S.
Pre-assignment Detail	A run-in period of 1 week (4 hemodialysis treatments) was required on the Tablo Hemodialysis System prior to the first period.

Arm/Group Title	In-Center Dialysis, Then In-Home Dialysis
Arm/Group Description	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)
Period Title: In-Center Period
STARTED	30
COMPLETED	30
NOT COMPLETED	0
Period Title: In-Center Period
STARTED	30
COMPLETED	28
NOT COMPLETED	2
Period Title: In-Center Period
STARTED	28
COMPLETED	28
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Intention-To-Treat (ITT) Population
Arm/Group Description	The ITT population was defined as all participants who were enrolled and fulfilled inclusion criteria.
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	27 90%
>=65 years	3 10%
Sex: Female, Male (Count of Participants)
Female	11 36.7%
Male	19 63.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 26.7%
Not Hispanic or Latino	21 70%
Unknown or Not Reported	1 3.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	13 43.3%
White	17 56.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	30 100%
Vascular Access Type (Count of Participants)
Fistula	23 76.7%
Catheter	4 13.3%
Graft	3 10%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	In-Center	In-Home
Arm/Group Description	Staff administered hemodialysis treatments for participants 4 times per week for 8 weeks In-Center using the Tablo system	Participants administered hemodialysis treatments In-Home using the Tablo system
Measure Participants	30	28
Mean (Standard Deviation) [Weekly Standardized Kt/V]	2.8 (0.3)	2.8 (0.3)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	In-Center	In-Home
Arm/Group Description	Staff administered hemodialysis treatments for participants In-Center using the Tablo system	Participants administered hemodialysis treatments In-Home using the Tablo system
Measure Participants	30	28
Number [Adverse Events]	2	6

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	In-Center	In-Home
Arm/Group Description	Staff administered hemodialysis treatments for participants In-Center using the Tablo system	Participants administered hemodialysis treatments In-Home using the Tablo system
Measure Participants	30	28
Number [Percentage of Dialysis Treatments]	94	94

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
Adverse Event Reporting Description	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: Pre-specified AEs (e.g., SAEs and/or treatment-related events) Unrelated to Tablo System Unrelated AEs were fully adjudicated for seriousness / relatedness, but were not assigned a specific AE term (MedDRA).
Arm/Group Title	In-Center		Transition Period		In-Home
Arm/Group Description	Staff administered hemodialysis treatments for participants 4 times per week for 8 weeks In-Center using the Tablo system		Staff and participant administered hemodialysis treatments using the Tablo system		Participants administered hemodialysis treatments In-Home using the Tablo system
All Cause Mortality
	In-Center		Transition Period		In-Home
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		1/30 (3.3%)		0/28 (0%)
Serious Adverse Events
	In-Center		Transition Period		In-Home
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/30 (3.3%)		2/30 (6.7%)		2/28 (7.1%)
Cardiac disorders
Cardiac Arrest	0/30 (0%)	0	1/30 (3.3%)	1	0/28 (0%)	0
Injury, poisoning and procedural complications
Fall	1/30 (3.3%)	1	0/30 (0%)	0	1/28 (3.6%)	2
Fluid Overload	0/30 (0%)	0	0/30 (0%)	0	1/28 (3.6%)	1
Skin and subcutaneous tissue disorders
Vascular Access Site Complication	0/30 (0%)	0	1/30 (3.3%)	1	0/28 (0%)	0
Other (Not Including Serious) Adverse Events
	In-Center		Transition Period		In-Home
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/30 (46.7%)		6/30 (20%)		10/28 (35.7%)
Injury, poisoning and procedural complications
Blood Loss from Dialyzer & Lines	1/30 (3.3%)	1	0/30 (0%)	0	2/28 (7.1%)	3
Investigations
Unrelated to Tablo System	13/30 (43.3%)	16	6/30 (20%)	9	9/28 (32.1%)	14

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.