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Comparison of Efficacy in Removal of Advanced Glycation End Products (AGEs) Between Super High-flux Hemodialysis and Postdilution Online Hemodiafiltration: A Single-center, Prospective, Open-label, Crossover Randomized Controlled Trial

Sponsor
Mahidol University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05777148
Collaborator
(none)
22
Enrollment
1
Location
2
Arms
14.9
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to compare efficacy in advanced glycation end products removal between Super high-flux Hemodialysis and high-volume post-dilution online hemodiafiltration. The main question it aims to answer are

  • Efficacy : endothelial dysfunction biomarker (AGEs) in super high-flux hemodialysis compared to online HDF

  • Safety profile : Dialysate albumin loss, Intradialytic complication

Participants will be asked to randomized in 2 groups : Super high-flux HD or post dilution ol-HDF Researchers will compare SHF-HD and ol-HDF to see whether SHF-HD could remove AGEs better than ol-HDF

Condition or Disease Intervention/Treatment Phase
  • Device: super high-flux hemodialysis
  • Device: postdilution online hemodiafiltration
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Efficacy in Removal of Advanced Glycation End Products (AGEs) Between Super High-flux Hemodialysis and Postdilution Online Hemodiafiltration: A Single-center, Prospective, Open-label, Crossover Randomized Controlled Trial
Actual Study Start Date :
Apr 4, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: postdilution online hemodiafiltration

hemodialysis by using post dilution online HDF technique

Device: postdilution online hemodiafiltration
hemodialysis by post dilution online HDF technique for 24 week then crossover to super high-flux HD (wash out period 4 weeks)
Experimental: super high-flux hemodialysis

hemodialysis by using super high-flux dialyzer

Device: super high-flux hemodialysis
Super high-flux hemodialysis (SHF-HD) is hemodialysis using Super high-flux dialyzer for 24 week then crossover to post dilution online HDF (wash out period 4 weeks)

Outcome Measures

Primary Outcome Measures

  1. skin autofluorescence for AGEs [24 weeks]

    SAF was measured by using a certified Autofluorescence Reader (AGE Reader, DiagnOptics, Groningen, The Netherlands). The AGEs reader uses an excitation light source between 300 and 420 nm to illuminate a skin surface that is about 1 cm2 in size and shielded from outside light. A spectrometer (AVS-USB2000, Avantes Inc., Eerbeek, The Netherlands) is used to measure the emission light from the skin in the 300- to 600-nm region using a 200-mm glass fiber.

Secondary Outcome Measures

  1. serum beta 2 microglobulin [At first week, 8th week, 16th week and 24th week]

    Measure mid-week prehemodialysis serum beta2 micro globulin

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Chronic HD > 3 months

  • Adequate small molecule uremic toxins removal

  • Kt/v > 1.8 in HD 2 times/week

  • Kt/v > 1.2 in HD 3 times/week

  • BFR > 300 mL/min

  • RKF < 100 ml/day

  • Hemodynamically stable for > 2 weeks

Exclusion Criteria:

  • contraindicated to anticoagulant

  • active malignancy

  • advanced liver disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 ramathibodi hospital, faculty of medicine, Ramathibodi hospital Phaya Thai Bangkok Thailand 10400

Sponsors and Collaborators

  • Mahidol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahidol University
ClinicalTrials.gov Identifier:
NCT05777148
Other Study ID Numbers:
  • 3619
First Posted:
Mar 21, 2023
Last Update Posted:
Mar 21, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mahidol University
hemodiafiltration
super high-flux hemodialysis
advanced glycation end products
Additional relevant MeSH terms:
Kidney Failure, Chronic

Study Results

No Results Posted as of Mar 21, 2023