40
Participants
Start Date
October 31, 2015
Primary Completion Date
October 31, 2026
Study Completion Date
December 31, 2026
Lixelle® treatment
The treatment will be performed with the Lixelle® column connected to upstream of the dialyzer in series on the routine HD circuit according to the description in the IFU. The dialyzer and the Kt/V urea in the conventional HD for each patient will be kept equal in Lixelle®-treatment. Since the maximum blood flow rate for Lixelle® is 250 ml/min, the dialysis time will be extended to achieve the target Kt/V urea. The study will not restrict the type of hemodialyzer and other conditions of HD as specified by the physician. However, any changes to the HD procedure should be recorded properly, and the Kt/V urea should be kept equal to that at the enrollment.
RECRUITING
The Rogosin Institute, New York
Kaneka Medical America LLC
INDUSTRY