Status:
COMPLETED
Clinical Study of Asahi ViE Dialyzer in Canada
Lead Sponsor:
Asahi Kasei Medical Co., Ltd.
Conditions:
Kidney Failure, Chronic
Eligibility:
All Genders
18-80 years
Phase:
NA
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, (...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
November 24 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2015
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02292212
Start Date
November 24 2014
End Date
November 6 2015
Last Update
December 11 2019
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