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Completed

NCT Number: NCT04211571

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

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyungpook national university chilgok hospital

Daegu, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Theranova 400 Dialyzer

Device

Hemodialysis using Theranova 400 dialyzer

High-flux dialyzer

Device

Hemodialysis using high-flux dialyzer

Other names: Fx CorDiax 80 dialyzer

Primary outcomes

  1. Change of glomerular filtration rate

    Time frame: 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 outcomes

  1. Change of glomerular filtration rate

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

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

  2. Change of daily urine volume

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

    Total urine output for 24 hours

  3. Change and reduction ratio of inflammatory marker levels

    Time frame: 0, 12 months

    TNF-alpha, GDF-15, etc.

  4. Change of hs-CRP

    Time frame: 0, 12 months

    hs-CRP

  5. Change of Beta 2-microglobulin

    Time frame: 0, 12 months

    Beta 2-microglobulin

  6. Change of kidney injury markers

    Time frame: 0, 12 months

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

  7. Change of cystatin-C

    Time frame: 0, 12 months

    Cystatin-C

  8. Change and reduction ratio of Kappa and lambda free light chains

    Time frame: 0, 12 months

    Kappa and lambda free light chains

  9. Hospitalization

    Time frame: Through 12-month study duration

    Frequency, cause, etc.

  10. Mortality

    Time frame: Through 12-month study duration

    Deaths number and causes of death

  11. Patient-reported outcome

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Collaborators

  • Baxter Healthcare Corporation
  • Ewha Womans University
  • Kyungpook National University Chilgok Hospital
  • Yeungnam University Hospital

Registry information

Official study title

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

Acronym: THREAD

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 26, 2019
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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