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

Primary Purpose

End Stage Renal Disease

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Theranova 400 dialyzer
High-flux dialyzer
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring End-stage renal disease, Medium cut-off dialyzer, High-flux dialyzer, Residual renal function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyungpook national university chilgok hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MCO group

High-flux group

Arm Description

Hemodialysis using Theranova 400 dialyzer

Hemodialysis using high-flux dialyzer (Fx CorDiax 60 and 80; Fresenius Medical Care)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2019
Last Updated
August 31, 2021
Sponsor
Kyungpook National University Hospital
Collaborators
Kyungpook National University Chilgok Hospital, Yeungnam University Hospital, Ewha Womans University, Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04211571
Brief Title
Theranova Versus High-flux Dialyzer on Preservation of Residual Renal Function
Official Title
Randomized Controlled Trial of Theranova Versus High-flux Dialyzer on Preservation of Residual Renal Function in Incident Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 23, 2020 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital
Collaborators
Kyungpook National University Chilgok Hospital, Yeungnam University Hospital, Ewha Womans University, Baxter Healthcare Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
End-stage renal disease, Medium cut-off dialyzer, High-flux dialyzer, Residual renal function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MCO group
Arm Type
Experimental
Arm Description
Hemodialysis using Theranova 400 dialyzer
Arm Title
High-flux group
Arm Type
Active Comparator
Arm Description
Hemodialysis using high-flux dialyzer (Fx CorDiax 60 and 80; Fresenius Medical Care)
Intervention Type
Device
Intervention Name(s)
Theranova 400 dialyzer
Intervention Description
Hemodialysis using Theranova 400 dialyzer
Intervention Type
Device
Intervention Name(s)
High-flux dialyzer
Other Intervention Name(s)
Fx CorDiax 60 and 80 dialyzer
Intervention Description
Hemodialysis using high-flux dialyzer
Primary Outcome Measure Information:
Title
Change of glomerular filtration rate
Description
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 Outcome Measure Information:
Title
Change of glomerular filtration rate
Description
Calculated as the mean of creatinine and urea clearance adjusted for body surface area
Time Frame
0, 12 months
Title
Change of daily urine volume
Description
Total urine output for 24 hours
Time Frame
0, 12 months
Title
Change of inflammatory marker levels
Description
hs-CRP, IL-6, TNF-alpha etc.
Time Frame
0, 12 months
Title
Blood concentration of Beta 2-microglobulin
Description
Pre-dialysis concentration
Time Frame
0, 12 months
Title
Blood concentration of Kappa and lambda free light chains
Description
Pre-dialysis concentration
Time Frame
0, 12 months
Title
Hospitalization
Description
Frequency, cause, length of hospital stay, etc.
Time Frame
Through 12-month study duration
Title
Mortality
Description
Deaths number and causes of death
Time Frame
Through 12-month study duration
Title
Patient-reported outcome
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong-Hoon Lim, MD, PhD
Phone
+82-53-200-5559
Email
hunph84@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jang-Hee Cho, MD, PhD
Phone
+82-53-200-5550
Email
jh-cho@knu.ac.kr
Facility Information:
Facility Name
Kyungpook national university chilgok hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong-Hoon Lim

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27587605
Citation
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. Erratum In: Nephrol Dial Transplant. 2021 Jul 23;36(8):1555-1556.
Results Reference
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Theranova Versus High-flux Dialyzer on Preservation of Residual Renal Function

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