A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of the Quanta Dialysis System for Home Hemodialysis
Bibliographic record
Abstract
Background: Hemodialysis (HD) treatments in the United States (US) are typically delivered in a dialysis center. Home hemodialysis (HHD) reduces costs to healthcare payors while providing more flexibility to patients with kidney failure. The QuantaTM Dialysis System (Quanta Dialysis System) is a modern, user-friendly HD device. Whether it is equally safe and effective when operated by patients and caregivers in the US at home vs. healthcare professionals at a center is unknown. The purpose of this study is to determine non-inferiority of efficacy and safety of the Quanta Dialysis System in self-care HHD vs. in-center HD. Methods: This is a prospective study set in 12 sites in the US. Adult patients with kidney failure currently undergoing dialysis for ≥90 days were eligible. Enrollment began November 2021 and continued during the Omicron wave of the COVID-19 pandemic. Participants received HD at their respective HHD training centers for 4-8-weeks. While dialyzing, participants and caregivers trained to use the device at home. Once deemed competent by a nephrology care team, participants performed supervised HHD during a transition week, then performed HHD with a care partner for 8 weeks. The primary efficacy outcome is dialysis adequacy measured by mean standardized weekly Kt/V. The primary safety outcome is a composite of adverse events. Results: As of April 2023, 23 patients were enrolled. The mean age was 55.5 ± 13.1 years, mean weight was 95.6 ± 20.4 kg, 10 (43.5%) participants were female, and 17 (73.9%) had a fistula or a graft for dialysis access. Only 4 (17.4%) participants have previously dialyzed with an HHD device. To date, 15 patients have transitioned from in-center HD to HHD, including 11 (73%) who achieved competency by the 5th week of training. Eight patients have completed the study. Conclusions: Data on successful completion of training suggests the Quanta Dialysis System is easy to use for patients with kidney failure in the US. As the final participants are projected to complete the study by August 2023, complete safety and efficacy comparisons between use of the Quanta Dialysis System in HHD vs. in-center HD will be reported at the time of presentation. Funding: Commercial Support - Quanta Dialysis Technologies
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".