Clinical trial NCT02460263: The EvAluation of TaBlo In-CLinic and In-HOme
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
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: Outset Medical
Sponsor class: INDUSTRY
First posted: 2015-06-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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)
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Weekly Standardized Dialysis Adequacy
timeFrame: 8 weeks per period
measure: Incidence of Pre-Specified Adverse Events
timeFrame: 8 weeks per period
Secondary outcomes:
measure: Ultrafiltration Rate Success
timeFrame: 8 weeks per period
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Outset Medical
state: California
Study officials:
References: