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Clinical Trial Summary

Traditional 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 indirectly lead to the death of patients. Studies have shown that, compared to conventional high-flux HD (HF-HD), 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 hemodialysis (HD) mode (hereinafter referred to as Theranova 400) compared to hemodiafiltration (HDF), using FX 800 in HDF mode (hereinafter referred to as FX 800).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05309291
Study type Interventional
Source Baxter Healthcare Corporation
Contact Baxter Clinical Trials Disclosure Call Center
Phone (224) 948-7359
Email Global_CORP_ClinicalTrialsDisclosure@baxter.com
Status Recruiting
Phase N/A
Start date June 29, 2022
Completion date September 30, 2023

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