End-stage Renal DiseaseNCT02092194
High Versus Standard Volume Hemodiafiltration in Asia
A study testing High Dose Online HDF and Standard Dose Online HDF in people with End-stage Renal Disease, run by Korean Hemodialysis Study Group at 6 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- High Dose Online HDF and Standard Dose Online HDF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Apr 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do
Sung Gyun Kim, MD, +82-31-380-3976, imnksk@gmail.com
Soo Jin Kim, MD, +82-10-8722-8078, dongangagy@lycos.co.kr
Chung-Ang University Hospital
Seoul
Su-Hyun Kim, MD, sh76so@cau.ac.kr
Su-Hyun Kim, MD
Korea University Anam Hospital
Seoul
Won-Yong Cho, MD, wonyong@korea.ac.kr
Won-Yong Cho, MD
Seoul National University Hospital
Seoul
Kwon Wook Joo, MD, junephro@snu.ac.kr
Kwon Wook Joo, MD
Shamyook Medical Center
Seoul
Sun Ryoung Choi, MD, ryounge@hanmail.net
Sun-Ryoung Choi, MD
Yonsei University Gangnam Severance Hospital
Seoul
Hyeong Cheon Park, MD, amp97@yuhs.ac
Hyeong Cheon Park, MD
About this study
Official title: 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.
- Conditions
- End-stage Renal Disease
- Being tested
- High Dose Online HDF, Standard Dose Online HDF
- Keywords
- beta 2-Microglobulin, Hemodiafiltration, convective volume
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose Online HDFProcedure or surgery
Also called High Volume online hemodiafiltration
Convection volume; 33-43 L/treatment (140-180 mL/min)
Standard Dose Online HDFProcedure or surgery
Also called Standard Volume online hemodiafiltration
convection volume; 16.8-21.5 L/treatment (70-90 mL/min)
| Study group | Role | What they receive |
|---|---|---|
| Standard Dose online HDF | Active comparator | Proposed target convection volume; 16.8-21.5 L/treatment (70-90 mL/min) Receives: Procedure: Standard Dose Online HDF |
| High Dose online HDF | Experimental | Proposed target convection volume; 33-43 L/treatment (140-180 mL/min). Receives: Procedure: High Dose Online HDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the serum concentration of β2 microglobulin
Measured: between baseline and 24 weeks after treatment
Secondary outcomes (5)
Dialysis Adequacy
Kt/V by the single pool variable volume formula.
Measured: 24 weeks
Inflammatory markers
C-reactive protein (CRP), interleukin-6, tumor necrosis factor-α.
Measured: 24 weeks
Nutritional status
normalized protein nitrogen appearance rate, serum albumin, serum protein, subjective global assessment (SGA)
Measured: 24 weeks
Intradialytic hypotension
Number of episode of symptomatic hypotension
Measured: 24 weeks
Quality of Life
SF-36-K (Korean version)
Measured: baseline and 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Hemodialysis Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd
- Responsible party
- Principal investigator, Sung Gyun Kim, Korean Hemodialysis Study Group
- Investigators
- Won-Yong Cho, MD, Study director, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092194
- Sponsor's protocol ID
- KHSG-201301
- Status last verified
- Mar 2014
- First submitted
- 17 Mar 2014
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High-volume Online Hemodiafiltration Compared to Standard Volume Online Hemodiafiltration. A Prospective, Multicenter, Randomized, Open-labelled Interventional Study.
- ClinicalTrials.gov ID
- NCT02092194
- Acronym / sponsor ID
- KHSG-201301
- Conditions
- End-stage Renal Disease
- Keywords
- beta 2-Microglobulin, Hemodiafiltration, convective volume
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Korean Hemodialysis Study GroupUniversity, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dose online HDF | Active comparator | Procedure: Standard Dose Online HDFProposed target convection volume; 16.8-21.5 L/treatment (70-90 mL/min) |
| High Dose online HDF | Experimental | Procedure: High Dose Online HDFProposed target convection volume; 33-43 L/treatment (140-180 mL/min). |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Dose Online HDFAlso: High Volume online hemodiafiltrationConvection volume; 33-43 L/treatment (140-180 mL/min) | Procedure or surgery | High Dose online HDF |
| Standard Dose Online HDFAlso: Standard Volume online hemodiafiltrationconvection volume; 16.8-21.5 L/treatment (70-90 mL/min) | Procedure or surgery | Standard Dose online HDF |
Primary outcome
changes in the serum concentration of β2 microglobulin
Time frame: between baseline and 24 weeks after treatment
5 secondary outcomes
Dialysis Adequacy
Time frame: 24 weeks
Inflammatory markers
Time frame: 24 weeks
Nutritional status
Time frame: 24 weeks
Intradialytic hypotension
Time frame: 24 weeks
Quality of Life
Time frame: baseline and 24 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won-Yong Cho, MD study director
Korea University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Dose Online HDF and Standard Dose Online HDF in people with End-stage Renal Disease, run by Korean Hemodialysis Study Group at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung Gyun Kim, MD (+82-10-3586-8561, imnksk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in the serum concentration of β2 microglobulin (time frame: between baseline and 24 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.