Effects of the NF-U PMMA Dialyzer on Quality of Life and the Clearance of Middle Molecules in Hemodialysis Patients

Effects of Polymethylmethacrylate dialyzer use on quality of life and middle molecule clearance in hemodialysis patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011884

Enrollment

Registered

2026-04-21

Start date

2026-04-30

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

None listed

Interventions

Medical Device : This study is an interventional study comparing a treatment group (NF-U polymethyl methacrylate dialyzer) and a control group (high-flux dialyzer) in maintenance hemodialysis patients

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged =18 years undergoing maintenance hemodialysis for at least 3 months 2. Patients receiving hemodialysis three times per week using a high-flux dialyzer 3. Patients with a total weekly dialysis duration of 12 hours 4. Patients with adequate dialysis (Kt/V >1.2) 5. Patients with a blood flow rate =200 mL/min and a dialysate flow rate of 500 mL/min 6. Patients receiving heparin as an anticoagulant 7. Patients who voluntarily provide written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Patients using a low-flux dialyzer 2. Patients receiving hemodialysis once or twice per week 3. Patients scheduled for kidney transplantation within 6 months 4. Patients with a history of hospitalization within the past 6 months 5. Patients with hematologic malignancy or monoclonal gammopathy 6. Patients diagnosed with a solid malignancy and currently undergoing treatment 7. Patients with active infection 8. Patients infected with human immunodeficiency virus 9. Patients who have participated in another clinical study within the past 3 months

Design outcomes

Primary

Measure	Time frame
Quality of life (QOL): EuroQol 5-Dimension (EQ-5D);Pruritus and fatigue: Visual Analog Scale (VAS), Patient-Reported Outcomes Measurement Information System(PROMIS) questionnaire;Nutritional parameters: Geriatric Nutritional Risk Index (GNRI), normalized Protein Catabolic Rate (nPCR), and albumin	—

Secondary

Measure	Time frame
Middle molecule clearance: ß2-microglobulin, kappa free light chain, and lambda free light chain ;Inflammatory markers: tumor necrosis factor-alpha (TNF-a), interleukin-6 (IL-6), growth differentiation factor-15 (GDF-15), high-sensitivity C-reactive protein (hs-CRP) ;Coagulation-related parameters: clotting events, prothrombin time (PT), activated partial thromboplastin time (aPTT), platelet count, D-dimer, and fibrinogen ;Routine laboratory tests: white blood cell count (WBC), hemoglobin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), ferritin, total iron-binding capacity (TIBC), iron, and intact parathyroid hormone (iPTH)	—

Measure

Time frame

Middle molecule clearance: ß2-microglobulin, kappa free light chain, and lambda free light chain ;Inflammatory markers: tumor necrosis factor-alpha (TNF-a), interleukin-6 (IL-6), growth differentiation factor-15 (GDF-15), high-sensitivity C-reactive protein (hs-CRP) ;Coagulation-related parameters: clotting events, prothrombin time (PT), activated partial thromboplastin time (aPTT), platelet count, D-dimer, and fibrinogen ;Routine laboratory tests: white blood cell count (WBC), hemoglobin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), ferritin, total iron-binding capacity (TIBC), iron, and intact parathyroid hormone (iPTH)

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Countries

Korea, Republic of

Contacts

Public ContactYou Hyun Jeon

Kyungpook National University Hospital

yh-jeon@knu.ac.kr+82-53-200-5505

Outcome results