The EvAluation of TaBlo In-CLinic and In-HOme

Study Overview
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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.

Official Title
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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

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Device: Tablo Hemodialysis System


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: 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 | 8 weeks per period | 

Secondary Outcome Measures

| Outcome Measure | 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. | 8 weeks per period |