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..
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.
- Conditions
- Kidney Failure, Chronic
- 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 group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | The 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.
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted17 Nov 2014 (estimated)
- Study start24 Nov 2014
- Primary completion6 Nov 2015
- Study completion6 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Asahi Kasei Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mercedeh Kiaii, MD, Principal investigator, St. Pauls Hospital
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Asahi ViE Dialyzer in Canada (AVID)
- ClinicalTrials.gov ID
- NCT02292212
- Acronym / sponsor ID
- AVID / AVID
- Conditions
- Kidney Failure, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Asahi Kasei Medical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2014 (actual)
- Primary completion
- 6 Nov 2015 (actual)
- Study completion
- 6 Nov 2015 (actual)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Posted 17 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: ViE-21The dialyzer will be changed from conventional one to ViE-21 for 36 sessions for all the enrolled subjects. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ViE-21The subjects will be undergone three times KUF measurement sessions and three times blood sampling sessions during study period. | Device | Single arm |
Primary outcome
Removal Rate of Urea
Time frame: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
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
Time frame: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
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
Time frame: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
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)
Time frame: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
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)
Time frame: Week 1 or 2 (Pre-ViE phase), 3-8 and 9-14 (ViE phase)
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)
Time frame: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
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
Time frame: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
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 )
Time frame: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
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%.
1 secondary outcome
Device Malfunctions
Time frame: Week 1 to 2 (Pre-ViE phase), 3 to 14 (ViE phase), and 15 to 16 (Post-ViE phase)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31254226Kiaii 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mercedeh Kiaii, MD principal investigator
St. Pauls Hospital
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.