The EvAluation of TaBlo In-CLinic and In-HOme

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-05-31

Brief Summary

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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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Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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In-Center

Staff administered treatments in-center using the device

Group Type PLACEBO_COMPARATOR

Tablo Hemodialysis System

Intervention Type DEVICE

In-Home

Patient administered treatments in-home using the device

Group Type EXPERIMENTAL

Tablo Hemodialysis System

Intervention Type DEVICE

Interventions

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Tablo Hemodialysis System

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No