N/A
N=17
Clinical Study of Asahi ViE Dialyzer in Canada
Kidney Failure, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT02292212 ↗Enrolled (actual)
17
Serious AEs
2.1%
Results posted
Aug 2017
Primary outcome: Primary: Removal Rate of Urea — 76.1; 74.4; 73.5 percentage of urea removal
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ViE-21 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Asahi Kasei Medical Co., Ltd.
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Removal Rate of Urea |
76.1; 74.4; 73.5 | — |
| PRIMARY Removal Rate of Creatinine |
70.7; 70.0; 69.0 | — |
| PRIMARY Removal Rate of Albumin |
2.4; -2.4; -1.0 | — |
| PRIMARY Removal Rate of Beta-2-microglobulin (B2-MG) |
65.5; 65.8; 65.9 | — |
| PRIMARY Ultrafiltration Coefficient (KUF) |
61.2; 67.8; 68.6 | — |
| PRIMARY White Blood Cell (WBC) |
82.3; 86.5; 92.7; 95.1; 94.1; 97.1 | — |
| PRIMARY Platelet |
94.6; 98.4; 98.2; 93.9; 99.0; 99.8 | — |
| PRIMARY Activated Complement Factor III (C3a ) |
224.1; 236.2; 198.1; 97.3; 103.1; 90.2 | — |
| SECONDARY Device Malfunctions |
0; 3; 0 | — |
Summary
The purpose of the study is to obtain performance data on the Asahi ViE-21 dialyzer (ViE-21) .
Eligibility Criteria
Inclusion Criteria
- Patients ≥ 18 years and ≤ 80 years of age
- Stable on maintenance hemodialysis for at least 12 weeks
- Patients expected to remain on hemodialysis for at least 24 weeks
- Patients on hemodialysis for more than 3 hours per treatment and on a 3 times per week schedule
- Patients whose vascular access is obtained via arteriovenous fistula or graft, is well maintained and is capable of obtaining blood flow rate ≥ 350 mL/min during the study period
- Patients using high-flux dialyzers (KUF ≥ 40 mL/hr/mmHg) with surface area ≥ 1.5 square meters and ≤ 2.2 square meters
- Patients capable of understanding the informed consent form
- Written consent and willingness to participate in the study
Exclusion Criteria
- Medical conditions requiring regular blood transfusion
- Patients with a history of more than one week hospitalization related to infection, inflammation or surgery within the past 12 weeks
- Patients having participated in another clinical investigation within the past 12 weeks, currently participating or having a plan of participating in any other clinical investigation (patients in an observational study without any interventions or in post-market surveillance do not need to be excluded)
- Patients who have difficulty in maintaining vascular access function within the past 12 weeks
- Patients who are known to be hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) positive
- Female patients who are pregnant, breast feeding or planning a pregnancy within the study period
- Patients having received blood purification therapy other than conventional dialysis within the past 12 weeks
- Patients who cannot tolerate Heparin
- Any serious medical, social or psychological condition that in the opinion of the investigator would disqualify a patient from participation
Data sourced from ClinicalTrials.gov (NCT02292212). 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.