UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063181 |
|---|---|
| Receipt number | R000072309 |
| Scientific Title | A nationwide cohort study on long-term outcomes of hemodiafiltration in incident dialysis patients: dose-response relationship of substitution volume |
| Date of disclosure of the study information | 2026/10/05 |
| Last modified on | 2026/10/05 19:43:37 |
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Basic information
Public title
A nationwide cohort study on long-term outcomes of hemodiafiltration in incident dialysis patients: dose-response relationship of substitution volume
Acronym
HDF volume and outcomes in incident dialysis
Scientific Title
A nationwide cohort study on long-term outcomes of hemodiafiltration in incident dialysis patients: dose-response relationship of substitution volume
Scientific Title:Acronym
HDF dose-response in incident dialysis
Region
| Japan |
Condition
Condition
End-stage kidney disease requiring dialysis initiation
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
All-cause mortality during follow-up from the exposure assessment time
Key secondary outcomes
1) Cardiovascular mortality and infection-related mortality (cause-specific Cox models)
2) Dose-response relationship between HDF substitution volume and all-cause mortality (restricted cubic splines)
3) Risk differences and restricted mean survival time (RMST) differences at 3, 5 and 8 years
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
380000
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Fujikura |
Organization
Hamamatsu University School of Medicine
Division name
Internal Medicine 1
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka
TEL
053-435-2261
tfuji@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Fujikura |
Organization
Hamamatsu University School of Medicine
Division name
Internal Medicine 1
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka
TEL
053-435-2261
Homepage URL
tfuji@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Japanese Society for Dialysis Therapy
Address
2-38-21 Hongo, Bunkyo-ku, Tokyo
Tel
03-5800-0708
office@jsdt.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
26-2
Org. issuing International ID_1
Medicine Ethics Committee of the Japanese Society for Dialysis Therapy
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
浜松医科大学（静岡県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
380000
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective cohort study (as-treated analysis) using secondary data from the Japanese Society for Dialysis Therapy Renal Data Registry (JRDR). Incident dialysis patients (January 2015 to September 2023) are classified into HD and HDF groups (substitution volume <40 L / 40-49 L / 50 L or more). Follow-up is up to approximately 9 years (administrative censoring at the end of 2024). All-cause mortality is analyzed by IPTW-weighted Cox models, with dose-response assessed using restricted cubic splines.
Management information
Registered date
| 2026 | Year | 10 | Month | 05 | Day |
Last modified on
| 2026 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072309
