search
Back to results

Clinical Study of Asahi ViE Dialyzer in Canada (AVID)

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ViE-21
Sponsored by
Asahi Kasei Medical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single arm

    Arm Description

    The dialyzer will be changed from conventional one to ViE-21 for 36 sessions for all the enrolled subjects.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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).
    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%.
    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%.
    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%.

    Secondary Outcome Measures

    Device Malfunctions

    Full Information

    First Posted
    October 28, 2014
    Last Updated
    November 27, 2019
    Sponsor
    Asahi Kasei Medical Co., Ltd.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02292212
    Brief Title
    Clinical Study of Asahi ViE Dialyzer in Canada
    Acronym
    AVID
    Official Title
    Clinical Study of Asahi ViE Dialyzer in Canada (AVID)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 24, 2014 (Actual)
    Primary Completion Date
    November 6, 2015 (Actual)
    Study Completion Date
    November 6, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Asahi Kasei Medical Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Failure, Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single arm
    Arm Type
    Experimental
    Arm Description
    The dialyzer will be changed from conventional one to ViE-21 for 36 sessions for all the enrolled subjects.
    Intervention Type
    Device
    Intervention Name(s)
    ViE-21
    Intervention Description
    The subjects will be undergone three times KUF measurement sessions and three times blood sampling sessions during study period.
    Primary Outcome Measure Information:
    Title
    Removal Rate of Urea
    Description
    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.
    Time Frame
    Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
    Title
    Removal Rate of Creatinine
    Description
    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.
    Time Frame
    Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
    Title
    Removal Rate of Albumin
    Description
    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.
    Time Frame
    Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
    Title
    Removal Rate of Beta-2-microglobulin (B2-MG)
    Description
    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.
    Time Frame
    Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
    Title
    Ultrafiltration Coefficient (KUF)
    Description
    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).
    Time Frame
    Week 1 or 2 (Pre-ViE phase), 3-8 and 9-14 (ViE phase)
    Title
    White Blood Cell (WBC)
    Description
    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%.
    Time Frame
    Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
    Title
    Platelet
    Description
    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%.
    Time Frame
    Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
    Title
    Activated Complement Factor III (C3a )
    Description
    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%.
    Time Frame
    Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
    Secondary Outcome Measure Information:
    Title
    Device Malfunctions
    Time Frame
    Week 1 to 2 (Pre-ViE phase), 3 to 14 (ViE phase), and 15 to 16 (Post-ViE phase)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mercedeh Kiaii, MD
    Organizational Affiliation
    St. Pauls Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31254226
    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.
    Results Reference
    result

    Learn more about this trial

    Clinical Study of Asahi ViE Dialyzer in Canada

    We'll reach out to this number within 24 hrs