Efficacy and Safety of Repeated-use Middle Cut Off Membrane Dialyzers in Hemodialysis Patients

NCT06950944 | Completed

• 1 other identifier: HE661417
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the efficacy of uremic toxin and inflammatory cytokine clearance by using reprocessing middle cutoff membrane (MCO) dialyzer in chronic hemodialysis patients. The main questions it aims to answer are:

• To evaluate efficacy of uremic toxin and inflammatory cytokine clearance and safty of hemodialysis with reprocessing MCO dialyzer compared with new MCO dialyzer
• To compare efficacy of uremic toxin and inflammatory cytokine clearance between 2 types of MCO dialyzer which availble in Thailand (Theranova 500 and Elisio 21Hx). Participants will randomized to 2 types of MCO groups after that they will receive hemodialysis by using study dialyzer with similar hemodialysis prescription. The dialyzer in this study were reprocessing by standard hospital protocol. Researchers will compare 2 types of dialyzer groups to see efficacy of uremic toxin and inflammatory cytokine clearance and safety of use reprocessing dialyzer.

Conditions

Hemodialysis; Hemodialysis Treatment; Dialysis Adequacy

Keywords

Middle cutoff membrane dialyzer; Uremic toxin clearance; Reused membrane dialyzer

Outcome Measures

Primary Outcomes (1)

• Efficacy of uremic toxin clearances from repeated-use middle cut off membrane dialyzers

  The efficacy of various-size uremic toxins removal including phosphorus, urea, creatinine, homocysteine, PTH, β2-MG, κ-FLC and λ-FLC together with inflammatory markers including IL-6 and C-reactive protein (CRP) were evaluated by pre- to post-dialysis reduction ratio (RRs) at 1st, 2nd, 5th, 10th, 15th session of dialysis intervention. The RR was calculated by the following equations according to Bergström and Wehle.

  up to 3 months or 12 weeks

Secondary Outcomes (2)

• Albumin loss from hemodialysis

  up to 3 months or 12 weeks

• Adveres event from reused middle cutoff membrane dialyzer

  up to 3 months or 12 weeks

Study Arms (2)

Theranova 500

EXPERIMENTAL

The participant underwent dialysis using the Theranova 500 dialyzer

Device: Theranova 500

Elisio 21Hx

ACTIVE COMPARATOR

The participant underwent dialysis using the Elisio 21Hx dialyzer

Device: Theranova 500

Interventions

Theranova 500 DEVICE

Participants will dialysis by Theranova 500 dialyzer during study period, the dialyzer will reprocessing with standard hospital protocol and dialyzer will check before use in dialysis session.

Elisio 21Hx; Theranova 500

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic hemodialysis with dialysis vintage more than 3 months
• hemodialysis via permanent vascular access (fistula or graft)
• adequate hemodialysis define with spKt/V \> 1.8 and \> 1.2 per session in twice and thrice weekly hemodialysis, respectively

You may not qualify if:

• preganancy
• hemodialysis vascular access dysfunction
• blood transmitted infection
• advanced malignancy or severe morbidity with life expectancy less than 1 year
• severe dialyzer reaction
• receive immunosuppressive drug

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Faculty of Medicine, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Nephrologist

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: April 30, 2025
• Study Start: January 1, 2024
• Primary Completion: March 31, 2024
• Study Completion: April 30, 2024
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)