High Versus Standard Volume Hemodiafiltration in Asia
Effectiveness of High-volume Online Hemodiafiltration Compared to Standard Volume Online Hemodiafiltration. A Prospective, Multicenter, Randomized, Open-labelled Interventional Study.
1 other identifier
interventional
60
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2014
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2014
CompletedFirst Posted
Study publicly available on registry
March 20, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 20, 2014
March 1, 2014
1.9 years
March 17, 2014
March 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changes in the serum concentration of β2 microglobulin
between baseline and 24 weeks after treatment
Secondary Outcomes (5)
Dialysis Adequacy
24 weeks
Inflammatory markers
24 weeks
Nutritional status
24 weeks
Intradialytic hypotension
24 weeks
Quality of Life
baseline and 24 weeks after treatment
Study Arms (2)
Standard Dose online HDF
ACTIVE COMPARATORProposed target convection volume; 16.8-21.5 L/treatment (70-90 mL/min)
High Dose online HDF
EXPERIMENTALProposed target convection volume; 33-43 L/treatment (140-180 mL/min).
Interventions
Convection volume; 33-43 L/treatment (140-180 mL/min)
convection volume; 16.8-21.5 L/treatment (70-90 mL/min)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korean Hemodialysis Study Grouplead
- Boryung Pharmaceutical Co., Ltdcollaborator
Study Sites (6)
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Shamyook Medical Center
Seoul, South Korea
Yonsei University Gangnam Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Won-Yong Cho, MD
Korea University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 17, 2014
First Posted
March 20, 2014
Study Start
April 1, 2014
Primary Completion
March 1, 2016
Study Completion
December 1, 2016
Last Updated
March 20, 2014
Record last verified: 2014-03