Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-28 @ 9:04 PM
Study NCT ID:
NCT02092194
Status:
UNKNOWN
Last Update Posted:
2014-03-20
First Post:
2014-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Versus Standard Volume Hemodiafiltration in Asia
Sponsor:
Korean Hemodialysis Study Group
Organization:
Study Overview
Official Title:
Effectiveness of High-volume Online Hemodiafiltration Compared to Standard Volume Online Hemodiafiltration. A Prospective, Multicenter, Randomized, Open-labelled Interventional Study.
Status:
UNKNOWN
Status Verified Date:
2014-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: