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High Versus Standard Volume Hemodiafiltration in Asia

Primary Purpose

End-stage Renal Disease

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High Dose Online HDF
Standard Dose Online HDF
Sponsored by
Korean Hemodialysis Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease focused on measuring beta 2-Microglobulin, Hemodiafiltration, convective volume

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients on thrice-weekly standard hemodialysis for > 3 months
  • Patients with a vascular access capable of delivering consistently a high blood flow rates ( ≥ 300 mL/min)
  • Patients willing to provide written informed consent.

Exclusion Criteria:

  • Patients with active infectious or uncontrolled inflammatory disorders
  • Patients with any uncontrolled malignant disease
  • Patients with recent major cardiovascular disease during the last 6 months
  • Patients who are likely to receive kidney transplant within the following 1 year
  • Patients whose life expectancy < 12 months
  • Patients considered by investigator to have difficulty in participation

Sites / Locations

  • Hallym University Sacred Heart Hospital
  • Chung-Ang University Hospital
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Shamyook Medical Center
  • Yonsei University Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Dose online HDF

High Dose online HDF

Arm Description

Proposed target convection volume; 16.8-21.5 L/treatment (70-90 mL/min)

Proposed target convection volume; 33-43 L/treatment (140-180 mL/min).

Outcomes

Primary Outcome Measures

changes in the serum concentration of β2 microglobulin

Secondary Outcome Measures

Dialysis Adequacy
Kt/V by the single pool variable volume formula.
Inflammatory markers
C-reactive protein (CRP), interleukin-6, tumor necrosis factor-α.
Nutritional status
normalized protein nitrogen appearance rate, serum albumin, serum protein, subjective global assessment (SGA)
Intradialytic hypotension
Number of episode of symptomatic hypotension
Quality of Life
SF-36-K (Korean version)

Full Information

First Posted
March 17, 2014
Last Updated
March 19, 2014
Sponsor
Korean Hemodialysis Study Group
Collaborators
Boryung Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02092194
Brief Title
High Versus Standard Volume Hemodiafiltration in Asia
Official Title
Effectiveness of High-volume Online Hemodiafiltration Compared to Standard Volume Online Hemodiafiltration. A Prospective, Multicenter, Randomized, Open-labelled Interventional Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korean Hemodialysis Study Group
Collaborators
Boryung Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Online hemodiafiltration (HDF) may improve clinical outcome in end-stage renal disease. The supported mechanism is the improved clearance of uremic toxins by convective transporter. However, It has not been elucidated which convection volume is optimal, especially in Asia. A total of 60 participants receiving conventional hemodialysis will be randomly assigned to receive either high dose convective volume (33-43 L/treatment) post-dilution online HDF or standard dose (16.8-21.5 L/treatment) for 24 weeks. The primary outcome is the change of serum β2 microglobulin levels between baseline and after 24 weeks. The secondary outcomes will include changes in the nutritional markers, inflammatory markers, and blood pressure from baseline to after treatment. This would be the first multicenter prospective, randomized controlled trial to determine whether large convective volume improves the treatment efficacy in Korean patients undergoing post-dilution online HDF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
Keywords
beta 2-Microglobulin, Hemodiafiltration, convective volume

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Standard Dose online HDF
Arm Type
Active Comparator
Arm Description
Proposed target convection volume; 16.8-21.5 L/treatment (70-90 mL/min)
Arm Title
High Dose online HDF
Arm Type
Experimental
Arm Description
Proposed target convection volume; 33-43 L/treatment (140-180 mL/min).
Intervention Type
Procedure
Intervention Name(s)
High Dose Online HDF
Other Intervention Name(s)
High Volume online hemodiafiltration
Intervention Description
Convection volume; 33-43 L/treatment (140-180 mL/min)
Intervention Type
Procedure
Intervention Name(s)
Standard Dose Online HDF
Other Intervention Name(s)
Standard Volume online hemodiafiltration
Intervention Description
convection volume; 16.8-21.5 L/treatment (70-90 mL/min)
Primary Outcome Measure Information:
Title
changes in the serum concentration of β2 microglobulin
Time Frame
between baseline and 24 weeks after treatment
Secondary Outcome Measure Information:
Title
Dialysis Adequacy
Description
Kt/V by the single pool variable volume formula.
Time Frame
24 weeks
Title
Inflammatory markers
Description
C-reactive protein (CRP), interleukin-6, tumor necrosis factor-α.
Time Frame
24 weeks
Title
Nutritional status
Description
normalized protein nitrogen appearance rate, serum albumin, serum protein, subjective global assessment (SGA)
Time Frame
24 weeks
Title
Intradialytic hypotension
Description
Number of episode of symptomatic hypotension
Time Frame
24 weeks
Title
Quality of Life
Description
SF-36-K (Korean version)
Time Frame
baseline and 24 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients on thrice-weekly standard hemodialysis for > 3 months Patients with a vascular access capable of delivering consistently a high blood flow rates ( ≥ 300 mL/min) Patients willing to provide written informed consent. Exclusion Criteria: Patients with active infectious or uncontrolled inflammatory disorders Patients with any uncontrolled malignant disease Patients with recent major cardiovascular disease during the last 6 months Patients who are likely to receive kidney transplant within the following 1 year Patients whose life expectancy < 12 months Patients considered by investigator to have difficulty in participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung Gyun Kim, MD
Phone
+82-10-3586-8561
Email
imnksk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Soo Jin Kim, MD
Phone
+82-10-8722-8078
Email
dongangagy@lycos.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won-Yong Cho, MD
Organizational Affiliation
Korea University
Official's Role
Study Director
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Gyun Kim, MD
Phone
+82-31-380-3976
Email
imnksk@gmail.com
First Name & Middle Initial & Last Name & Degree
Soo Jin Kim, MD
Phone
+82-10-8722-8078
Email
dongangagy@lycos.co.kr
First Name & Middle Initial & Last Name & Degree
Sung Gyun Kim, MD
First Name & Middle Initial & Last Name & Degree
Soo Jin Kim, MD
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su-Hyun Kim, MD
Email
sh76so@cau.ac.kr
First Name & Middle Initial & Last Name & Degree
Su-Hyun Kim, MD
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won-Yong Cho, MD
Email
wonyong@korea.ac.kr
First Name & Middle Initial & Last Name & Degree
Won-Yong Cho, MD
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwon Wook Joo, MD
Email
junephro@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Kwon Wook Joo, MD
Facility Name
Shamyook Medical Center
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Ryoung Choi, MD
Email
ryounge@hanmail.net
First Name & Middle Initial & Last Name & Degree
Sun-Ryoung Choi, MD
Facility Name
Yonsei University Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyeong Cheon Park, MD
Email
amp97@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Hyeong Cheon Park, MD

12. IPD Sharing Statement

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High Versus Standard Volume Hemodiafiltration in Asia

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