High Versus Standard Volume Hemodiafiltration in Asia

End-stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02092194
• Other study ID #: KHSG-201301
• Status: Not yet recruiting
• Phase: N/A
• First received: March 17, 2014
• Last updated: March 19, 2014
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2014
• Source: Korean Hemodialysis Study Group
• Contact: Sung Gyun Kim, MD
• Phone: +82-10-3586-8561
• Email: imnksk[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Procedure:
• High Dose Online HDF
Convection volume; 33-43 L/treatment (140-180 mL/min)
• Standard Dose Online HDF
convection volume; 16.8-21.5 L/treatment (70-90 mL/min)

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang	Gyeonggi-do
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Shamyook Medical Center	Seoul
Korea, Republic of	Yonsei University Gangnam Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korean Hemodialysis Study Group	Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in the serum concentration of ß2 microglobulin		between baseline and 24 weeks after treatment	No
Secondary	Dialysis Adequacy	Kt/V by the single pool variable volume formula.	24 weeks	No
Secondary	Inflammatory markers	C-reactive protein (CRP), interleukin-6, tumor necrosis factor-a.	24 weeks	No
Secondary	Nutritional status	normalized protein nitrogen appearance rate, serum albumin, serum protein, subjective global assessment (SGA)	24 weeks	No
Secondary	Intradialytic hypotension	Number of episode of symptomatic hypotension	24 weeks	Yes
Secondary	Quality of Life	SF-36-K (Korean version)	baseline and 24 weeks after treatment	No