NCT04211571

Theranova Versus High-flux Dialyzer on Preservation of Residual Renal Function

Randomized Controlled Trial of Theranova Versus High-flux Dialyzer on Preservation of REsidual RenAl Function in Incident HemoDialysis Patients (THREAD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Kyungpook National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Theranova is a novel medium cut-off dialyzer and has better performance for removal of middle molecules compared to conventional hemodialysis. The study investigates the effect of Theranova dialzyer on preserving residual renal function in the incident hemodialysis pateitns compared to high-flux dialzyer. The primary endpoint is change of glomerular filtration rate, calculated using creatinine and urea clearance. The secondary endpoints are serial changes of glomerular filtration rate and daily urine volume, changes of serum middle molecule concentrations, hospitalization, mortality, and patient reported outcomes.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	Theranova 400 dialyzer	Hemodialysis using Theranova 400 dialyzer
DEVICE	High-flux dialyzer	Hemodialysis using high-flux dialyzer

Timeline

• Start date: 2020-04-23
• Primary completion: 2023-09-17
• Completion: 2023-09-24
• First posted: 2019-12-26
• Last updated: 2023-11-21

Locations

1 site across 1 country: South Korea