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

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 glomerular filtration rate, daily urine volume, serum middle molecule concentrations, hospitalization, mortality, and patient reporeted outcomes.

Full Title of Study: “Randomized Controlled Trial of Theranova Versus High-flux Dialyzer on Preservation of Residual Renal Function in Incident Hemodialysis Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2021

Interventions

  • Device: Theranova 400 dialyzer
    • Hemodialysis using Theranova 400 dialyzer
  • Device: High-flux dialyzer
    • Hemodialysis using high-flux dialyzer

Arms, Groups and Cohorts

  • Experimental: MCO group
    • Hemodialysis using Theranova 400 dialyzer
  • Active Comparator: High-flux group
    • Hemodialysis using high-flux dialyzer (Fx CorDiax 60 and 80; Fresenius Medical Care)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Change of glomerular filtration rate
    • Time Frame: 0, 12 months
    • Calculated as the mean of creatinine and urea clearance adjusted for body surface area
  • Change of daily urine volume
    • Time Frame: 0, 12 months
    • Total urine output for 24 hours
  • Change of inflammatory marker levels
    • Time Frame: 0, 12 months
    • hs-CRP, IL-6, TNF-alpha etc.
  • Blood concentration of Beta 2-microglobulin
    • Time Frame: 0, 12 months
    • Pre-dialysis concentration
  • Blood concentration of Kappa and lambda free light chains
    • Time Frame: 0, 12 months
    • Pre-dialysis concentration
  • Hospitalization
    • Time Frame: Through 12-month study duration
    • Frequency, cause, length of hospital stay, etc.
  • Mortality
    • Time Frame: Through 12-month study duration
    • Deaths number and causes of death
  • 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)

Participating in This Clinical Trial

Inclusion Criteria

  • Incident end-stage renal disease ESRD patient receiving hemodialysis for less than 1 month
  • 18 years old and older
  • Vascular access by arteriovenous fistula/graft
  • Creatinine clearance of more than 2 ml/min
  • Agreement to participate in the clinical study

Exclusion Criteria

  • Dialysis through permanent catheter
  • Plan for kidney transplantation within 6 months
  • Severe volume overloading state
  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kyungpook National University Hospital
  • Collaborator
    • Kyungpook National University Chilgok Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yong-Lim Kim, M.D., Ph.D. – Kyungpook National University Hospital
  • Overall Contact(s)
    • Jeong-Hoon Lim, MD, PhD, +82-53-200-5559, hunph84@naver.com

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.