Tokyo, Oct. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063398) titled 'Comparison of how well two types of dialysis membranes remove substances from the blood: a study in which each patient uses both membranes in turn' on Oct. 24.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Shimada Hospital, Jyosuikai Medical Corporation

Condition: Condition - End-stage kidney disease on maintenance on-line hemodiafiltration Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To estimate the within-patient differences in removal rates of beta2-microglobulin, lysozyme and alpha1-microglobulin, and their variability, between PMMA (PMF-21A) and polysulfone (ABH-22PA) membranes in on-line HDF patients who are not eligible for Lixelle. Clinical symptoms are not evaluated. The estimates will be used to design a future confirmatory trial. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Group X (n=6): PS membrane ABH-22PA (2.2 m2) in period 1 (2 weeks, about 6 sessions) -> PMMA membrane PMF-21A (2.1 m2) in period 2 (4 weeks) -> return to ABH-22PA after the study. On-line HDF. Dialysis conditions other than the membrane are fixed throughout. Evaluation blood sampling (pre/post dialysis): Nov 9-10 (period 1) and Dec 7-8 (period 2). Interventions/Control_2 - Group Y (n=6): PMMA membrane PMF-21A (2.1 m2) in period 1 (2 weeks, about 6 sessions) -> PS membrane ABH-22PA (2.2 m2) in period 2 (4 weeks). On-line HDF. Dialysis conditions other than the membrane are fixed throughout. Evaluation blood sampling (pre/post dialysis): Nov 9-10 (period 1) and Dec 7-8 (period 2).

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Able to receive on-line HDF stably. (2) Currently using ABH-22PA. (3) Not meeting the criteria for Lixelle, or not using it. (4) Written informed consent obtained after sufficient explanation. (5) No serious complications such as severe infection or malignancy. Key exclusion criteria - [Exclusion criteria] History of hypersensitivity or allergy to PMMA or polysulfone membranes. [Discontinuation criteria] Participants will be withdrawn if any of the following occur during the study: (1) serious infection, surgery or hospitalization; (2) change of dialysis conditions (blood flow, dialysate flow, dialysis time, replacement volume); (3) adverse events such as allergy to the membrane; (4) blood sampling difficult for technical reasons; (5) withdrawal of consent. Target Size - 12

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2026 Year 10 Month 09 Day Date of IRB - 2026 Year 10 Month 09 Day Anticipated trial start date - 2026 Year 10 Month 26 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072516

Disclaimer: Curated by HT Syndication.