High Versus Standard Volume Hemodiafiltration in Asia

Korean Hemodialysis Study Group

Status: Unknown

Conditions: End-stage Renal Disease

Treatments: Procedure: High Dose Online HDF; Procedure: Standard Dose Online HDF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02092194

KHSG-201301

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Standard Dose online HDF

Active Comparator group

Description:

Proposed target convection volume; 16.8-21.5 L/treatment (70-90 mL/min)

Treatment:

Procedure: Standard Dose Online HDF

High Dose online HDF

Experimental group

Description:

Proposed target convection volume; 33-43 L/treatment (140-180 mL/min).

Treatment:

Procedure: High Dose Online HDF