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ClinicalTrials.gov ID

NCT02092194

Lead Sponsor

Korean Hemodialysis Study GroupOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

60Estimated

Last Update Posted

Mar 20, 2014Estimated

Start Date

Apr 2014

Primary Completion Date

Mar 2016Estimated

Completion Date

Dec 2016Estimated

Official Title

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

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.

• End-stage Renal Disease

• High Dose Online HDF
• Standard Dose Online HDF

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Korean Hemodialysis Study GroupOTHER

Collaborators

Boryung Pharmaceutical Co., LtdINDUSTRY

sh76so@cau.ac.kr

wonyong@korea.ac.kr

junephro@snu.ac.kr

ryounge@hanmail.net

amp97@yuhs.ac