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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05777148
Enrollment
22
Registered
2023-03-21
Start date
2022-04-04
Completion date
2023-06-30
Last updated
2023-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

hemodiafiltration, super high-flux hemodialysis, advanced glycation end products

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

Interventions

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)

DEVICEpostdilution online hemodiafiltration

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

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
skin autofluorescence for AGEs24 weeksSAF 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

MeasureTime frameDescription
serum beta 2 microglobulinAt first week, 8th week, 16th week and 24th weekMeasure mid-week prehemodialysis serum beta2 micro globulin

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026