Post Approval Study of Lixelle for the Treament of Dialysis-Related Amyloidosis

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

October 31, 2026

Study Completion Date

December 31, 2026

Conditions
Dialysis Amyloidosis
Interventions
DEVICE

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.

Trial Locations (1)

10021

RECRUITING

The Rogosin Institute, New York

All Listed Sponsors
lead

Kaneka Medical America LLC

INDUSTRY