Abstract: SA-PO1079
A Study to Evaluate a New Hemodialysis Device in the Home
Session Information
- Home Hemodialysis
November 09, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 702 Dialysis: Home Hemodialysis
Authors
- Plumb, Troy J., University of Nebraska Medical Center, Omaha, Nebraska, United States
- Mulhern, Jeffrey, Fresenius Kidney Care Pioneer Valley Dialysis, Springfield, Massachusetts, United States
- Prichard, Sarah S., Independent Consultant, Montreal, Quebec, Canada
- Lim, Brittany, Outset Medical, San Jose, California, United States
- Aragon, Michael A., Outset Medical, San Jose, California, United States
Background
The Tablo® Hemodialysis system is an automated, sensor-based system that simplifies operation and produces on demand dialysate without the need for separate water treatment. It is currently indicated for use in acute and chronic care settings.
The purpose of this study was to describe the patient population enrolled in a home study and the rate of adherence to the dialysis frequency protocol requirement.
Methods
A prospective multicenter, open-label, non-randomized, cross-over study was completed to evaluate Tablo in the home by subjects with end stage renal disease (ESRD) who are on stable dialysis regimens. The FDA-approved study required an In-Center arm with 32 treatments, a transition period of 8-16 treatments, and an In-Home arm with 32 treatments. Dialysis frequency was 4 times per week. The primary efficacy endpoint was a weekly standardized Kt/V of ≥ 2.1, and the primary safety endpoint was the mean number of adverse events from a pre-specified list. The secondary endpoint was ultrafiltration (UF) rate within 10% of the prescribed UF goal.
Results
Thirty patients from 8 dialysis units in the US were enrolled, and 28 per-protocol patients completed 1742 treatments. Compliance to the protocol dialysis frequency in the per-protocol group was 97%. Preliminary analysis suggests the study met all safety and efficacy endpoints.
Conclusion
Patients in the study were representative of the overall dialysis population. Protocol compliance was high and preliminary data indicates study objectives were achieved.
Baseline Clinical Data
| Demographics Variable | Category | Overall (N=30) |
| Gender | Male | 19 (63.3%) |
| Age | Mean | 52 |
| Range | 26-71 | |
| BMI | Mean | 31.8 |
| Range | 22.2-40.5 | |
| Race/Ethnicity | White | 9 (30.0%) |
| Hispanic | 8 (26.7%) | |
| Black or African American | 13 (43.3%) | |
| Access Type | Fistula | 23 (76.7%) |
| Catheter | 4 (13.3%) | |
| Graft | 3 (10.0%) | |
| Primary Cause of ESRD | Diabetes | 14 (46.7%) |
| Hypertension | 3 (10.0%) | |
| Failed Transplant | 3 (10.0%) | |
| PCKD | 2 (6.7%) | |
| Glomerulonephritis | 1 (3.3%) | |
| Other | 7 (23.3%) | |
| Pre-dialysis Systolic BP (mmHg) | Mean | 153.4 |
| Range | 109-188 | |
| Pre-study modality | In-center dialysis | 16 (53%) |
Funding
- Commercial Support – Outset Medical