Traditional hemodialysis (HD) therapy is very effective in clearing urea and smaller middle molecules, but is limited in clearing larger middle molecules. These accumulated large middle-molecular-weight uremic toxins may cause and aggravate inflammation, atherosclerosis and calcification, which can indirectly lead to the death of patients. Studies have shown that, compared to conventional high-flux HD (HF-HD), hemodiafiltration (HDF) that combines diffusion and convection can reduce the all-cause mortality. Compared to the conventional HF-HD, HDF can more effectively clear larger molecular toxins in one session, which may be related to the better clearance effect of HDF on middle-molecular-weight toxins Theranova's innovative Medium Cut-Off® membranes has high permeability and selectivity to uremic toxins (clearance of a molecular weight of up to 45 kDa) and can retain essential proteins, to maintain patient's albumin level during the HD treatment\[9\]. Its unique membrane and high cut-off characteristics expand the clearance range beyond those of flux membrane dialyzers. Theranova 400 can be widely used in most blood purification centers under conventional HD equipment and treatment modes, with the effect similar to HDF This study is to demonstrate non-inferiority of the Theranova 400 Dialyzer in HD mode (hereinafter referred to as Theranova 400) compared to HDF, using FX 800 in HDF mode (hereinafter referred to as FX 800).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
323
Dialysis performed in HD mode.
Dialysis performed in HDF mode.
Investigational Site
Beijing, China
Investigational Site
Beijing, China
Investigational Site
Dalian, China
Investigational Site
Dalian, China
Investigational Site
Hangzhou, China
Investigational Site
Nanjing, China
Investigational Site
Shanghai, China
Investigational Site
Shanghai, China
Investigational Site
Shenzhen, China
Investigational Site
Suzhou, China
Reduction Ratio (RR) of Lambda Free Light Chains (λ FLC)
One mid-week treatment day dialysis session, pre-dialysis and post-dialysis. The RR was calculated using the following formula: \[(Cpre-Cpost)/Cpre\], where Cpre and Cpost were the arterial plasma concentrations of λ FLC measured pre- and post- the mid-week dialysis session, respectively
Time frame: Assessed at the mid-week treatment day dialysis session
Reduction Ratio of Beta-2 Microglobulin (β2-MG)
One mid-week treatment day dialysis session, pre-dialysis and post-dialysis. The RR was calculated using the following formula: \[(Cpre-Cpost)/Cpre\], where Cpre and Cpost were the arterial plasma β2-MG concentrations measured pre- and post- the mid-week dialysis session, respectively.
Time frame: Assessed at the mid-week treatment day dialysis session
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