Clinical Study of Asahi ViE Dialyzer in Canada

NCT ID: NCT02292212

Last Updated: 2019-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-24
• Study Completion Date: 2015-11-06

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.

Conditions

Kidney Failure, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

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

Group Type: EXPERIMENTAL

ViE-21

Intervention Type: DEVICE

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

Interventions

ViE-21

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asahi Kasei Medical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mercedeh Kiaii, MD

Role: PRINCIPAL_INVESTIGATOR

St. Pauls Hospital

References

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.

Reference Type: RESULT

PMID: 31254226 (View on PubMed)

Other Identifiers

AVID

Identifier Type: -

Identifier Source: org_study_id