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

Study Overview
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Brief Summary
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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.

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

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Device: Theranova 400 dialyzer
* Device: High-flux dialyzer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 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 | 
| Change and reduction ratio of Kappa and lambda free light chains | Kappa and lambda free light chains | 0, 12 months | 
| Hospitalization | Frequency, cause, etc. | Through 12-month study duration | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End-stage renal disease, Medium cut-off dialyzer, High-flux dialyzer, Residual renal function