NCT05309291

Theranova Randomized, Controlled, Trial (RCT) in China

A Randomized, Open-label, Controlled, Parallel, Multicenter Study in Kidney Failure Patients on Hemodialysis Comparing the Theranova Dialyzer to Hemodiafiltration

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Chronic Kidney Failure
• Acute Kidney Failure

Interventions

Type	Name	Description
DEVICE	Theranova 400 Dialyzer	Dialysis performed in HD mode.
DEVICE	FX 800 Dialyzer	Dialysis performed in HDF mode.

Timeline

• Start date: 2022-06-22
• Primary completion: 2023-07-06
• Completion: 2023-07-06
• First posted: 2022-04-04
• Last updated: 2025-07-14
• Results posted: 2024-10-15

Locations

10 sites across 1 country: China