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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04211571

Acronym

THREAD

Enrollment

Registered

2019-12-26

Start date

2020-04-23

Completion date

2023-09-24

Last updated

2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

End-stage renal disease, Medium cut-off dialyzer, High-flux dialyzer, Residual renal function

Brief 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.

Interventions

DEVICETheranova 400 dialyzer

Hemodialysis using Theranova 400 dialyzer

DEVICEHigh-flux dialyzer

Hemodialysis using high-flux dialyzer

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Change of glomerular filtration rate	Between baseline and 12 months	Glomerular filtration rate is calculated as the mean of creatinine and urea clearance adjusted for body surface area. The outcome refers to the mean difference of glomerular filtration rate between baseline and after 12 months.

Secondary

Measure	Time frame	Description
Change of daily urine volume	0, 3, 6, 9, 12 months	Total urine output for 24 hours
Change and reduction ratio of inflammatory marker levels	0, 12 months	TNF-alpha, GDF-15, etc.
Change of hs-CRP	0, 12 months	hs-CRP
Change of Beta 2-microglobulin	0, 12 months	Beta 2-microglobulin
Change of kidney injury markers	0, 12 months	NGAL, KIM-1, TIMP-2, IGFBP-7, etc
Change of glomerular filtration rate	0, 3, 6, 9, 12 months	Calculated as the mean of creatinine and urea clearance adjusted for body surface area
Change and reduction ratio of Kappa and lambda free light chains	0, 12 months	Kappa and lambda free light chains
Hospitalization	Through 12-month study duration	Frequency, cause, etc.
Mortality	Through 12-month study duration	Deaths number and causes of death
Patient-reported outcome	0, 12 months	Using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™; score ranges from 0 to 100 - higher scores represent better quality of life)
Change of cystatin-C	0, 12 months	Cystatin-C

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026