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

Kyungpook National University

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Device: High-flux dialyzer; Device: Theranova 400 dialyzer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04211571

KNU-Theranova-01

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Incident end-stage renal disease ESRD patient receiving hemodialysis for less than 1 month
• 18 years old and older
• Creatinine clearance of more than 2 ml/min
• Agreement to participate in the clinical study
• Vascular access by arteriovenous fistula/graft

Exclusion criteria

• Plan for kidney transplantation within 6 months
• Severe volume overloading state
• Dialysis through permanent catheter
• Any hematologic malignancy or monoclonal gammopathy
• Any malignancy
• Active infectious disease
• HIV infection
• Patient enrolled to another study within 3 month from starting the present study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

MCO group

Experimental group

Description:

Hemodialysis using Theranova 400 dialyzer

Treatment:

Device: Theranova 400 dialyzer

High-flux group

Active Comparator group

Description:

Hemodialysis using high-flux dialyzer (Fx CorDiax 80; Fresenius Medical Care)

Treatment:

Device: High-flux dialyzer