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

Kyungpook National University Hospital80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Between baseline and 12 months

Secondary Outcomes

Change of glomerular filtration rate

Calculated as the mean of creatinine and urea clearance adjusted for body surface area

Time frame: 0, 3, 6, 9, 12 months

Change of daily urine volume

Total urine output for 24 hours

Time frame: 0, 3, 6, 9, 12 months

Change and reduction ratio of inflammatory marker levels

TNF-alpha, GDF-15, etc.

Time frame: 0, 12 months

Change of hs-CRP

hs-CRP

Time frame: 0, 12 months

Change of Beta 2-microglobulin

Beta 2-microglobulin

Time frame: 0, 12 months

Change of kidney injury markers

NGAL, KIM-1, TIMP-2, IGFBP-7, etc

Time frame: 0, 12 months

Change of cystatin-C

Cystatin-C

Time frame: 0, 12 months

Change and reduction ratio of Kappa and lambda free light chains

Kappa and lambda free light chains

Time frame: 0, 12 months

Hospitalization

Frequency, cause, etc.

Time frame: Through 12-month study duration

Mortality

Deaths number and causes of death

Time frame: 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)

Time frame: 0, 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes