Clinical trial NCT02292212: Clinical Study of Asahi ViE Dialyzer in Canada
Official title: Clinical Study of Asahi ViE Dialyzer in Canada (AVID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Lead sponsor: Asahi Kasei Medical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-11-17
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to obtain performance data on the Asahi ViE-21 dialyzer (ViE-21) .

Detailed description: The objective of the study is to evaluate specific parameters related to ViE-21 performance including (A) Performance evaluated by uremic solute removal rates of urea, creatinine, albumin and B2-MG, (B) Determination of KUF, (C) Biocompatibility evaluated by WBC, platelet and C3a measurements, (D) Type and number of adverse events, (E) Type and number of device malfunctions.

Prospective, open-label, non-randomized, single-armed, controlled study. Each patient shall have data collected for six dialysis sessions each on a control dialyzer prior to and after 36 sessions with the ViE-21. These data shall be the basis of comparison for the ViE-21 performance.

These data will be utilized in support of a US Regulatory Submission.

Eligibility criteria: Inclusion Criteria:

1. Patients ≥ 18 years and ≤ 80 years of age
2. Stable on maintenance hemodialysis for at least 12 weeks
3. Patients expected to remain on hemodialysis for at least 24 weeks
4. Patients on hemodialysis for more than 3 hours per treatment and on a 3 times per week schedule
5. 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
6. Patients using high-flux dialyzers (KUF ≥ 40 mL/hr/mmHg) with surface area ≥ 1.5 square meters and ≤ 2.2 square meters
7. Patients capable of understanding the informed consent form
8. Written consent and willingness to participate in the study

Exclusion Criteria:

1. Medical conditions requiring regular blood transfusion
2. Patients with a history of more than one week hospitalization related to infection, inflammation or surgery within the past 12 weeks
3. 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)
4. Patients who have difficulty in maintaining vascular access function within the past 12 weeks
5. Patients who are known to be hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) positive
6. Female patients who are pregnant, breast feeding or planning a pregnancy within the study period
7. Patients having received blood purification therapy other than conventional dialysis within the past 12 weeks
8. Patients who cannot tolerate Heparin
9. Any serious medical, social or psychological condition that in the opinion of the investigator would disqualify a patient from participation

Primary outcomes:
measure: Removal Rate of Urea
timeFrame: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
measure: Removal Rate of Creatinine
timeFrame: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
measure: Removal Rate of Albumin
timeFrame: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
measure: Removal Rate of Beta-2-microglobulin (B2-MG)
timeFrame: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
measure: Ultrafiltration Coefficient (KUF)
timeFrame: Week 1 or 2 (Pre-ViE phase), 3-8 and 9-14 (ViE phase)
measure: White Blood Cell (WBC)
timeFrame: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
measure: Platelet
timeFrame: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
measure: Activated Complement Factor III (C3a )
timeFrame: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
Secondary outcomes:
measure: Device Malfunctions
timeFrame: Week 1 to 2 (Pre-ViE phase), 3 to 14 (ViE phase), and 15 to 16 (Post-ViE phase)
Other outcomes:
Locations:
Study officials:
affiliation: St. Pauls Hospital
name: Mercedeh Kiaii, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kiaii M, Aritomi M, Nagase M, Farah M, Jung B. Clinical evaluation of performance, biocompatibility, and safety of vitamin E-bonded polysulfone membrane hemodialyzer compared to non-vitamin E-bonded hemodialyzer. J Artif Organs. 2019 Dec;22(4):307-315. doi: 10.1007/s10047-019-01110-w. Epub 2019 Jun 26.