N/A
Completed N=30
The EvAluation of TaBlo In-CLinic and In-HOme
Source: ClinicalTrials.gov NCT02460263 ↗Enrolled (actual)
30
Serious AEs
5.7%
Results posted
Jul 2020
Primary outcomePrimary: Weekly Standardized Dialysis Adequacy — 2.8; 2.8 Weekly Standardized Kt/V
Summary
The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center by trained individuals and In-Home by trained Subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weekly Standardized Dialysis Adequacy |
2.8; 2.8 | — |
| PRIMARY Incidence of Pre-Specified Adverse Events |
2; 6 | — |
| SECONDARY Ultrafiltration Rate Success |
94; 94 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has end stage renal disease (ESRD) adequately treated by maintenance dialysis achieving a Kt/V ≥ 1.2 and has been deemed stable for at least three months by his/her treating nephrologist.
- Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min.
Exclusion Criteria
- Life expectancy less than 12 months from first study procedure.
- Subject has had a recent major cardiovascular adverse event within the last 3 months.
- Subject has New York Class III or IV Congestive Heart Failure, or ejection fraction less than 30%.
- Subject with fluid overload due to intractable ascites secondary to liver cirrhosis.
- Subject has uncontrolled blood pressure.
- Subject is intolerant to heparin.
- Subject is seroreactive for Hepatitis B Surface Antigen.
- Subject has an active, life-threatening, rheumatologic disease.
- Subject has a history of adverse reactions to dialyzer membrane material.
- Subject is expected to receive an organ transplant during the course of the study.
- Subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol.
Data sourced from ClinicalTrials.gov (NCT02460263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.