End Stage Renal Disease
Conditions
Keywords
Tablo, Outset Medical, ESRD, Home Hemodialysis, HHD, ESKD
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.
Interventions
Home hemodialysis treatments \ 4 times a week.
Sponsors
Outset Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Standardized Dialysis Adequacy | 12-months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health Outcomes | Change from Baseline at 12-months | 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. |
| Sleep Outcomes | Change from Baseline at 12-months | 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. |
| Care Partner Burden | Change from Baseline at 12-months | 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. |
Countries
United States
Contacts
Primary ContactJosh Schumacher
Outcome results
None listed