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Kidney Failure, ChronicAVIDNCT02292212

Clinical Study of Asahi ViE Dialyzer in Canada

A study testing ViE-21 in people with Kidney Failure, Chronic, run by Asahi Kasei Medical Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to obtain performance data on the Asahi ViE-21 dialyzer (ViE-21) . Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Kidney Failure, Chronic
What is being tested?
ViE-21
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
No sites listed yet
Study dates
24 Nov 2014to 6 Nov 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

About this study

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

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

Read the 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.

Being tested
ViE-21
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ViE-21Device

    The subjects will be undergone three times KUF measurement sessions and three times blood sampling sessions during study period.

Study groups in NCT02292212
Study groupRoleWhat they receive
Single armExperimentalThe dialyzer will be changed from conventional one to ViE-21 for 36 sessions for all the enrolled subjects.
Receives: Device: ViE-21

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)

  2. 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.

    Measured: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)

  3. 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.

    Measured: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)

  4. 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.

    Measured: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)

  5. 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).

    Measured: Week 1 or 2 (Pre-ViE phase), 3-8 and 9-14 (ViE phase)

  6. 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%.

    Measured: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)

  7. 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%.

    Measured: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)

  8. 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%.

    Measured: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)

Secondary outcomes (1)
  1. Device Malfunctions

    Measured: Week 1 to 2 (Pre-ViE phase), 3 to 14 (ViE phase), and 15 to 16 (Post-ViE phase)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2014 (estimated)
  2. Study start24 Nov 2014
  3. Primary completion6 Nov 2015
  4. Study completion6 Nov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02292212
Sponsor's protocol ID
AVID
Acronym
AVID
Status last verified
Nov 2019
First submitted
28 Oct 2014
Last updated
11 Dec 2019
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31254226

Questions about this trial

What is this clinical trial studying?

A study testing ViE-21 in people with Kidney Failure, Chronic, run by Asahi Kasei Medical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Removal Rate of Urea (time frame: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02292212, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.

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