In China, the estimated prevalence of patients with ESRD receiving PD or maintenance HD increased from 51.7 per million population (pmp) at the end of 2007 to 79.1 pmp at the end of 2008. Theranova 400 is designed to deliver the performance of hemodiafiltration (HDF) using standard hemodialysis (HD) equipment and treatment mode, including HD machines, disposables, blood and dialysate flows, length of treatment and frequency of treatment. Theranova 400 utilizes a Medium Cut-Off (MCO) membrane with extended permeability for middle solutes to closely modulate the removal function of the kidney without the complexity of HDF. The primary objective of the study is to demonstrate non-inferiority of the Theranova Dialyzer in hemodialysis (HD) mode compared to hemodiafiltration (HDF), using FX 800 in HDF mode. Comparison of the study arms over time will be used to support the safety of Theranova 400 by demonstrating stable serum albumin levels, as well as support the dialyzer's efficacy to significantly remove serum middle molecules.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
Dialysis performed in HD mode. Treatment duration for each individual subject will vary based on clinical requirements determined by the Investigator, based on the subject's need, residual renal function, access function, tolerance to HD/HDF and other relevant factors. The participating subjects' HD/HDF prescriptions should be kept stable throughout the study.
Dialysis performed in HDF mode. Treatment duration for each individual subject will vary based on clinical requirements determined by the Investigator, based on the subject's need, residual renal function, access function, tolerance to HD/HDF and other relevant factors. The participating subjects' HD/HDF prescriptions should be kept stable throughout the study.
Investigational Site
Hefei, Anhui, China
Investigational Site
Guangzhou, Guangdong, China
Investigational Site
Zhengzhou, Henan, China
Investigational Site
Wuhan, Hubei, China
Investigational Site
Shanghai, Shanghai Municipality, China
Investigational Site
Chengdu, Sichuan, China
Investigational Site
Hangzhou, Zhejiang, China
Investigational Site
Beijing, China
Reduction ratio of lambda free light chains (λ FLC)
At the first mid-week treatment day
Time frame: Up to 1 week
Reduction ratio of β2 microglobulin
At the first mid-week treatment day
Time frame: Up to 1 week
Pre-dialysis serum albumin
Time frame: Study Completion (Week 12)
Kt/V urea
Mid-Week Treatment Day
Time frame: Week 1, Week 5, Week 9, Week 13
Urea reduction ratio (URR)
Mid-Week Treatment Day
Time frame: Week 1, Week 5, Week 9, Week 13
Pre-dialysis serum levels of λ FLC
Mid-Week Treatment Day
Time frame: Week 1, Week 5, Week 9, Week 13
Pre-dialysis serum levels of β2 microglobulin
Mid-Week Treatment Day
Time frame: Week 1, Week 5, Week 9, Week 13
Reduction ratio of α1 microglobulin (α1M)
At the first mid-week treatment day
Time frame: Up to 1 week
Reduction ratio of Chitinase-3-like protein (YKL-40)
At the first mid-week treatment day
Time frame: Up to 1 week
Reduction ratio of complement factor D (CFD)
At the first mid-week treatment day
Time frame: Up to 1 week
Reduction ratio of myoglobin
At the first mid-week treatment day
Time frame: Up to 1 week
Reduction ratio of kappa free light chains (κ FLC)
At the first mid-week treatment day
Time frame: Up to 1 week
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