Clinical Study of Asahi ViE Dialyzer in Canada

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

Detailed Description
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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.

Official Title
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Clinical Study of Asahi ViE Dialyzer in Canada (AVID)

Conditions
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Kidney Failure, Chronic

Intervention / Treatment
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* Device: ViE-21


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>The dialyzer will be changed from conventional one to ViE-21 for 36 sessions for all the enrolled subjects. | Device: ViE-21<br>* The subjects will be undergone three times KUF measurement sessions and three times blood sampling sessions during study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Removal Rate of Urea | In order to calculate removal rate for urea by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation with Pre-dialysis concentration (Cpre) and Post-dialysis concentration (Cpost) of urea. Removal rate (%) = [(Cpre - Cpost) / (Cpre)] * 100. The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively. | Week 1 (Pre-ViE phase), 7, 13 (ViE phase) | 
| Removal Rate of Creatinine | In order to calculate removal rate for creatinine by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation. Removal rate (%) = [(Cpre - Cpost) / (Cpre)] * 100. The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively. | Week 1 (Pre-ViE phase), 7, 13 (ViE phase) | 
| Removal Rate of Albumin | In order to calculate removal rate for albumin by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation with hematocrit (HCT) at pre (HCTpre) and post (HCTpost). Removal rate (%) = {1-[HCTpre*(1-HCTpost/100) * Cpost] / [HCTpost * (1-HCTpre/100) * Cpre]} * 100. The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively. The negative removal rate means the increase of serum concentration of albumin from pre to post dialysis session. | Week 1 (Pre-ViE phase), 7, 13 (ViE phase) | 
| Removal Rate of Beta-2-microglobulin (B2-MG) | In order to calculate removal rate for B2-MG by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation. Removal rate (%) = {1-[HCTpre*(1-HCTpost/100) * Cpost] / [HCTpost * (1-HCTpre/100) * Cpre]} * 100. The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively. | Week 1 (Pre-ViE phase), 7, 13 (ViE phase) | 
| Ultrafiltration Coefficient (KUF) | The KUF is important for regulating the rate and amount of fluid flow across the dialyzer membrane. It is calculated by dividing ultrafiltration rate with the transmembrane pressure (TMP). More specifically, transmembrane pressures were recorded at 10, 20, 30, 40 and 50 minutes after the initiation of the dialysis session with adjustment of the ultrafiltration rate at 0, 600, 1000, 1400 and 1800 mL/hr respectively. These determinations were made during the 2nd or 3rd treatment session during the 1st or 2nd week for control dialyzer (Pre-ViE phase), and for ViE-21 during week 3-8 and week 9-14 (ViE phase). | Week 1 or 2 (Pre-ViE phase), 3-8 and 9-14 (ViE phase) | 
| White Blood Cell (WBC) | Blood samples were obtained during the first week of dialysis with control dialyzer and then during weeks 7 and 13 with ViE-21. WBC count was measured pre dialysis, at 15 minutes and post dialysis. The values were corrected with HCT and then leveled by defining the pre-dialysis value as 100%. | Week 1 (Pre-ViE phase), 7, 13 (ViE phase) | 
| Platelet | Blood samples were obtained during the first week of dialysis with control dialyzer and then during weeks 7 and 13 with ViE-21. Platelet count was measured pre dialysis, at 15 minutes and post dialysis. The values were corrected with HCT and then leveled by defining the pre-dialysis value as 100%. | Week 1 (Pre-ViE phase), 7, 13 (ViE phase) | 
| Activated Complement Factor III (C3a ) | Blood samples were obtained during the first week of dialysis with control dialyzer and then during weeks 7 and 13 with ViE-21. C3a was measured pre dialysis, at 15 minutes and post dialysis. The values were corrected with HCT and then leveled by defining the pre-dialysis value as 100%. | Week 1 (Pre-ViE phase), 7, 13 (ViE phase) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Malfunctions |  | Week 1 to 2 (Pre-ViE phase), 3 to 14 (ViE phase), and 15 to 16 (Post-ViE phase) |