High Versus Standard Volume Hemodiafiltration in Asia

March 19, 2014 updated by: Sung Gyun Kim, Korean Hemodialysis Study Group

Effectiveness of High-volume Online Hemodiafiltration Compared to Standard Volume Online Hemodiafiltration. A Prospective, Multicenter, Randomized, Open-labelled Interventional Study.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sung Gyun Kim, MD
  • Phone Number: +82-10-3586-8561
  • Email: imnksk@gmail.com

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Kwon Wook Joo, MD
      • Seoul, Korea, Republic of
        • Yonsei University Gangnam Severance Hospital
        • Contact:
        • Principal Investigator:
          • Hyeong Cheon Park, MD
      • Seoul, Korea, Republic of
        • Chung-ang University Hospital
        • Contact:
        • Principal Investigator:
          • Su-Hyun Kim, MD
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
        • Contact:
        • Principal Investigator:
          • Won-Yong Cho, MD
      • Seoul, Korea, Republic of
        • Shamyook Medical Center
        • Contact:
        • Principal Investigator:
          • Sun-Ryoung Choi, MD
    • Gyeonggi-do
      • Anyang, Gyeonggi-do, Korea, Republic of
        • Hallym University Sacred Heart Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sung Gyun Kim, MD
        • Sub-Investigator:
          • Soo Jin Kim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Dose online HDF
Proposed target convection volume; 16.8-21.5 L/treatment (70-90 mL/min)
Procedure: Standard Dose Online HDF
convection volume; 16.8-21.5 L/treatment (70-90 mL/min)
Other Names:
  • Standard Volume online hemodiafiltration
Experimental: High Dose online HDF
Proposed target convection volume; 33-43 L/treatment (140-180 mL/min).
Procedure: High Dose Online HDF
Convection volume; 33-43 L/treatment (140-180 mL/min)
Other Names:
  • High Volume online hemodiafiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in the serum concentration of β2 microglobulin
Time Frame: between baseline and 24 weeks after treatment
between baseline and 24 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dialysis Adequacy
Time Frame: 24 weeks
Kt/V by the single pool variable volume formula.
24 weeks
Inflammatory markers
Time Frame: 24 weeks
C-reactive protein (CRP), interleukin-6, tumor necrosis factor-α.
24 weeks
Nutritional status
Time Frame: 24 weeks
normalized protein nitrogen appearance rate, serum albumin, serum protein, subjective global assessment (SGA)
24 weeks
Intradialytic hypotension
Time Frame: 24 weeks
Number of episode of symptomatic hypotension
24 weeks
Quality of Life
Time Frame: baseline and 24 weeks after treatment
SF-36-K (Korean version)
baseline and 24 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korean Hemodialysis Study Group

Collaborators

Boryung Pharmaceutical Co., Ltd

Investigators

  • Study Director: Won-Yong Cho, MD, Korea University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Estimate)

March 20, 2014

Last Update Submitted That Met QC Criteria

March 19, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHSG-201301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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