Clinical Study of Asahi ViE Dialyzer in Canada

Clinical Study of Asahi ViE Dialyzer in Canada (AVID)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02292212

Acronym

AVID

Enrollment

Registered

2014-11-17

Start date

2014-11-24

Completion date

2015-11-06

Last updated

2019-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

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.

Interventions

DEVICEViE-21

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Activated Complement Factor III (C3a )	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%.
Removal Rate of Creatinine	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	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 Urea	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 Beta-2-microglobulin (B2-MG)	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)	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)	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	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%.

Secondary

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

Participant flow

Recruitment details

The patients on hemodialysis at one clinical site in Canada were enrolled to this study. The first patient was enrolled on November 24, 2014 and the last patient on July 13, 2015.

Participants by arm

Arm	Count
Single Arm Total 16 weeks, divided to 3 phases, Pre-ViE phase (2W by control device), ViE phase (12W by target device, ViE-21) and Post-ViE phase (2W by control device).	17
Total	17

Withdrawals & dropouts

Period	Reason	FG000
ViE Phase	Protocol Violation	2
ViE Phase	Withdrawal by Subject	1

Baseline characteristics

Characteristic	Single Arm
Age, Continuous	69.4 years STANDARD_DEVIATION 10
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants
Race/Ethnicity, Customized Asian	2 Participants
Race/Ethnicity, Customized Asian Filipino	4 Participants
Race/Ethnicity, Customized Asian Indian	2 Participants
Race/Ethnicity, Customized Asian Sri Lankan	1 Participants
Race/Ethnicity, Customized Black or African American	0 Participants
Race/Ethnicity, Customized Caucasian	7 Participants
Race/Ethnicity, Customized Hispanic	0 Participants
Race/Ethnicity, Customized Native Canadian	1 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants
Sex: Female, Male Female	5 Participants
Sex: Female, Male Male	12 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 17	0 / 17	0 / 14
other Total, other adverse events	16 / 17	17 / 17	11 / 14
serious Total, serious adverse events	0 / 17	0 / 17	1 / 14

Outcome results

Primary

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%.

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