Home With TablO outcoMEs (HOME) Registry

End Stage Renal Disease Clinical Trial

— HOME  

Official title:

Home With TablO outcoMEs (HOME) Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04526301
• Other study ID #: 2020-02
• Status: Recruiting
• Start date: July 14, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: August 2022
• Source: Outset Medical
• Contact: Josh Schumacher
• Phone: (669) 231-8200
• Email: ClinicalTeam[@]outsetmedical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• Tablo Hemodialysis System
Home hemodialysis treatments ~4 times a week.

Locations

Country	Name	City	State
United States	St. Peter's Health	Helena	Montana
United States	Dialysis Center of Lincoln	Lincoln	Nebraska
United States	Parker Jewish Institute	New Hyde Park	New York
United States	NYU Grossman School of Medicine	New York	New York
United States	Rogosin Institute	New York	New York
United States	Berkshire Medical Center	Pittsfield	Massachusetts
United States	USRC Kidney Research	Plano	Texas
United States	Satellite Healthcare, Inc.	San Jose	California
United States	University of Virginia	Staunton	Virginia
United States	Desert Cities Dialysis	Victorville	California

Sponsors (1)

Lead Sponsor	Collaborator
Outset Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Outcomes	Change in health outcomes from baseline to 12-months, as measured by the 12-item Short Form Health Survey (SF-12) Questionnaire. The questionnaire consists of 12 items weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100. Higher scores mean a better outcome.	Change from Baseline at 12-months
Other	Sleep Outcomes	Change in sleep from baseline to 12-months, as measured by the Insomnia Severity Index (ISI). The minimum and maximum values are 0 and 28 scores, respectively. Higher scores mean a worse outcome.	Change from Baseline at 12-months
Other	Care Partner Burden	Change in care partner burden from baseline to 12-months, as measured by the Zarit Burden Interview-12 (ZBI-12) scale. The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating a worse outcome.	Change from Baseline at 12-months
Primary	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