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Clinical Study of Asahi ViE Dialyzer in Canada — AVID  

Kidney Failure, Chronic Clinical Trial

Official title:
Clinical Study of Asahi ViE Dialyzer in Canada (AVID)

Clinical Trial Summary

The purpose of the study is to obtain performance data on the Asahi ViE-21 dialyzer (ViE-21) .

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02292212
Study type Interventional
Source Asahi Kasei Medical Co., Ltd.
Contact
Status Completed
Phase N/A
Start date November 24, 2014
Completion date November 6, 2015
View Details
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