The EvAluation of TaBlo In-CLinic and In-HOme

NCT02460263 | Completed Results

• 1 other identifier: 2014-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• 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: 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

  8 weeks per period

Secondary Outcomes (1)

• Ultrafiltration Rate Success

  8 weeks per period

Study Arms (2)

In-Center

PLACEBO COMPARATOR

Staff administered treatments in-center using the device

Device: Tablo Hemodialysis System

In-Home

EXPERIMENTAL

Patient administered treatments in-home using the device

Device: Tablo Hemodialysis System

Interventions

Tablo Hemodialysis System DEVICE

In-Center; In-Home

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Outset Medical: lead

Study Sites (1)

Outset Medical

San Jose, California, 95112, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Operations
• Organization: Outset Medical, Inc

clinical@outsetmedical.com

(669) 231-8200

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: June 2, 2015
• Study Start: December 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 1, 2020
• Results First Posted: July 1, 2020

Record last verified: 2020-06

Locations

US (1)