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The purpose of the study is to obtain performance data on the Asahi ViE-21 dialyzer (ViE-21) .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | The dialyzer will be changed from conventional one to ViE-21 for 36 sessions for all the enrolled subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ViE-21 | Device | The subjects will be undergone three times KUF measurement sessions and three times blood sampling sessions during study period. |
|
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mercedeh Kiaii, MD | St. Pauls Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31254226 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Total 16 weeks, divided to 3 periods, Pre-ViE phase (2W by control device), ViE phase (12W by target device, ViE-21) and Post-ViE phase (2W by control device). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-ViE Phase |
| |||||||||||||
| ViE Phase |
| |||||||||||||
| Post-ViE Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21. | Posted | Mean | Standard Deviation | percentage of urea removal | Week 1 (Pre-ViE phase), 7, 13 (ViE phase) |
|
Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-ViE Phase | Two weeks (six sessions) on control dialyzer | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Masaharu Aritomi, Ph.D. | Asahi Kasei Medical Co., Ltd. | aritomi.mb@om.asahi-kasei.co.jp |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| 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) |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | ViE Phase (1) | Seventh week of dialysis with ViE-21 |
| OG002 | ViE Phase (2) | 13th week of dialysis with ViE-21 |
|
|
| Primary | 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. | The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21. | Posted | Mean | Standard Deviation | percentage of creatinine removal | Week 1 (Pre-ViE phase), 7, 13 (ViE phase) |
|
|
|
| Primary | 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. | The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21. | Posted | Mean | Standard Deviation | percentage of albumin removal | Week 1 (Pre-ViE phase), 7, 13 (ViE phase) |
|
|
|
| Primary | 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. | The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21. | Posted | Mean | Standard Deviation | percentage of B2MG removal | Week 1 (Pre-ViE phase), 7, 13 (ViE phase) |
|
|
|
| Primary | 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). | The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21. | Posted | Mean | Standard Deviation | mL/(hr*mmHg) | Week 1 or 2 (Pre-ViE phase), 3-8 and 9-14 (ViE phase) |
|
|
|
| Primary | 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%. | The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21. | Posted | Mean | Standard Deviation | percentage of WBC level | Week 1 (Pre-ViE phase), 7, 13 (ViE phase) |
|
|
|
| Primary | 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%. | The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21. | Posted | Mean | Standard Deviation | percentage of platelet level | Week 1 (Pre-ViE phase), 7, 13 (ViE phase) |
|
|
|
| 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%. | The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21. | Posted | Mean | Standard Deviation | percentage of C3a level | Week 1 (Pre-ViE phase), 7, 13 (ViE phase) |
|
|
|
| Secondary | Device Malfunctions | The safety analysis population (SAA) that is comprised of all patients that received at least one session with the ViE-21 | Posted | Number | malfunctions | Week 1 to 2 (Pre-ViE phase), 3 to 14 (ViE phase), and 15 to 16 (Post-ViE phase) |
|
|
|
| 17 |
| 0 |
| 17 |
| 16 |
| 17 |
| EG001 | ViE Phase | 12 weeks (36 sessions) on ViE-21 | 0 | 17 | 0 | 17 | 17 | 17 |
| EG002 | Post-ViE Phase | Two weeks (six sessions) on the same model control dialyzer used during the pre-ViE phase | 0 | 14 | 1 | 14 | 11 | 14 |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Fluid Overload | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Angioplasty | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
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