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

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Device: Theranova 400 dialyzer; Device: High-flux dialyzer

• Registration Number: NCT04211571
• Lead Sponsor: Kyungpook National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-21
• Study First Submitted QC: 2019-12-21
• Study First Posted: 2019-12-26
• Study Start: 2020-04-23
• Primary Completion: 2023-09-17
• Study Completion: 2023-09-24
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-19
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MCO group	Theranova 400 dialyzer	Hemodialysis using Theranova 400 dialyzer
High-flux group	High-flux dialyzer	Hemodialysis using high-flux dialyzer (Fx CorDiax 80; Fresenius Medical Care)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change of daily urine volume	0, 3, 6, 9, 12 months	Total urine output for 24 hours
Change of hs-CRP	0, 12 months	hs-CRP
Change of kidney injury markers	0, 12 months	NGAL, KIM-1, TIMP-2, IGFBP-7, etc
Mortality	Through 12-month study duration	Deaths number and causes of death
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 inflammatory marker levels	0, 12 months	TNF-alpha, GDF-15, etc.
Change of cystatin-C	0, 12 months	Cystatin-C
Change and reduction ratio of Kappa and lambda free light chains	0, 12 months	Kappa and lambda free light chains
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 Beta 2-microglobulin	0, 12 months	Beta 2-microglobulin
Hospitalization	Through 12-month study duration	Frequency, cause, etc.

Trial Locations

Locations (1)

Kyungpook national university chilgok hospital; 🇰🇷 Daegu, Korea, Republic of