Tokyo, Oct. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063181) titled 'A nationwide cohort study on long-term outcomes of hemodiafiltration in incident dialysis patients: dose-response relationship of substitution volume' on Oct. 5.
Study Type:
Observational
Primary Sponsor:
Institute - Hamamatsu University School of Medicine
Condition:
Condition - End-stage kidney disease requiring dialysis initiation
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine whether hemodiafiltration (HDF), compared with hemodialysis (HD), reduces all-cause mortality in incident dialysis patients, and whether a dose-response relationship exists between HDF substitution volume (<40 L / 40-49 L / 50 L or more) and all-cause mortality.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who initiated maintenance dialysis between January 2015 and September 2023 at facilities participating in the JSDT Renal Data Registry (JRDR)
Key exclusion criteria - Age <18 years; history of PD or kidney transplantation before HD/HDF initiation; death, transplantation or loss to follow-up before the exposure assessment time; not thrice-weekly dialysis; session <4 h; blood flow <180 mL/min; excluded modalities (offline/push-pull HDF, AFBF, IHDF, home HD, etc.); combined HD/HDF or PD therapy
Target Size - 380000
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2026 Year 08 Month 20 Day
Date of IRB - 2026 Year 08 Month 20 Day
Anticipated trial start date - 2026 Year 08 Month 20 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=R000072309
Disclaimer: Curated by HT Syndication.
