Clinical trial NCT02092194: 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
Overall status: UNKNOWN
Phase: NA
Conditions: End-stage Renal Disease
Keywords: beta 2-Microglobulin
Hemodiafiltration
convective volume
Lead sponsor: Korean Hemodialysis Study Group
Sponsor class: OTHER
Collaborators: name: Boryung Pharmaceutical Co., Ltd
First posted: 2014-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: changes in the serum concentration of β2 microglobulin
timeFrame: between baseline and 24 weeks after treatment
Secondary outcomes:
measure: Dialysis Adequacy
timeFrame: 24 weeks
measure: Inflammatory markers
timeFrame: 24 weeks
measure: Nutritional status
timeFrame: 24 weeks
measure: Intradialytic hypotension
timeFrame: 24 weeks
measure: Quality of Life
timeFrame: baseline and 24 weeks after treatment
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Shamyook Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Gangnam Severance Hospital
Study officials:
affiliation: Korea University
name: Won-Yong Cho, MD
role: STUDY_DIRECTOR
References: