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Completed

NCT Number: NCT02460263

The EvAluation of TaBlo In-CLinic and In-HOme

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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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outset Medical

San Jose, California, 95112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tablo Hemodialysis System

Device

Primary outcomes

  1. Weekly Standardized Dialysis Adequacy

    Time frame: 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

    Time frame: 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 outcomes

  1. Ultrafiltration Rate Success

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Outset Medical

Industry

Registry information

Official study 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

Acronym: TABLO

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 2, 2015
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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