NCT04526301

Brief Summary

Prospective, multicenter, single arm, post-market study to evaluate real world clinical outcomes in ESRD patients receiving in-home dialysis on the Tablo Hemodialysis System.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

September 23, 2022

Status Verified

August 1, 2022

Enrollment Period

4 years

First QC Date

August 14, 2020

Last Update Submit

September 22, 2022

Conditions

End Stage Renal Disease

Keywords

TabloOutset MedicalESRDHome HemodialysisHHDESKD

Outcome Measures

Primary Outcomes (1)

  • Weekly Standardized Dialysis Adequacy

    Weekly standardized dialysis adequacy (stdKt/V) 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.

    12-months

Other Outcomes (3)

  • Health Outcomes

    Change from Baseline at 12-months

  • Sleep Outcomes

    Change from Baseline at 12-months

  • Care Partner Burden

    Change from Baseline at 12-months

Study Arms (1)

Tablo Hemodialysis System

Home dialysis treatment with the Tablo Hemodialysis System

Device: Tablo Hemodialysis System

Interventions

Tablo Hemodialysis SystemDEVICE

Home hemodialysis treatments \~4 times a week.

Tablo Hemodialysis System

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with end stage renal disease (ESRD) who are on, or planning to be on, maintenance hemodialysis.

You may qualify if:

  • Participant (patient and/or care partner) is at least 15 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
  • Participant weighs ≥ 34kg.
  • Participant has end stage renal disease (ESRD) adequately treated by maintenance dialysis.
  • Participant plans to start or has started home treatment (≤ 6 months) with the Tablo Hemodialysis System.
  • Participant is willing and able to comply with the Protocol requirements and perform all site required treatments and clinical evaluations.

You may not qualify if:

  • Participant and/or care partner is unable to read English or Spanish.
  • Participant has a home environment that is deemed inappropriate for home dialysis.
  • Participant and/or care partner is unable to successfully complete the Tablo training program
  • Participant is pregnant or plans to become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Satellite Healthcare, Inc.

San Jose, California, 95128, United States

RECRUITING

Desert Cities Dialysis

Victorville, California, 92395, United States

COMPLETED

Berkshire Medical Center

Pittsfield, Massachusetts, 01201, United States

RECRUITING

St. Peter's Health

Helena, Montana, 59601, United States

RECRUITING

Dialysis Center of Lincoln

Lincoln, Nebraska, 68512, United States

RECRUITING

Parker Jewish Institute

New Hyde Park, New York, 11040, United States

RECRUITING

NYU Grossman School of Medicine

New York, New York, 10016, United States

RECRUITING

Rogosin Institute

New York, New York, 10021, United States

RECRUITING

USRC Kidney Research

Plano, Texas, 75024, United States

RECRUITING

University of Virginia

Staunton, Virginia, 24401, United States

WITHDRAWN

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Josh Schumacher

CONTACT

(669) 231-8200ClinicalTeam@outsetmedical.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2020

First Posted

August 25, 2020

Study Start

July 14, 2020

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

September 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(10)