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

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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Device: Theranova 400 dialyzer; Device: High-flux dialyzer

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Kyungpook National University Chilgok Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MCO group; Hemodialysis using Theranova 400 dialyzer	Device: Theranova 400 dialyzer; Hemodialysis using Theranova 400 dialyzer
Active Comparator: High-flux group; Hemodialysis using high-flux dialyzer (Fx CorDiax 80; Fresenius Medical Care)	Device: High-flux dialyzer; Hemodialysis using high-flux dialyzer; Other Names: Fx CorDiax 80 dialyzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of glomerular filtration rate	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.	Between baseline and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital
• Collaborators: Baxter Healthcare Corporation; Kyungpook National University Chilgok Hospital; Yeungnam University Hospital; Ewha Womans University

Publications and helpful links

General Publications

• Kirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310. Erratum In: Nephrol Dial Transplant. 2021 Jul 23;36(8):1555-1556.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2020
• Primary Completion (Actual): September 17, 2023
• Study Completion (Actual): September 24, 2023

Study Registration Dates

• First Submitted: December 21, 2019
• First Submitted That Met QC Criteria: December 21, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: End-stage renal disease; Medium cut-off dialyzer; High-flux dialyzer; Residual renal function
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: KNU-Theranova-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No