UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057713 |
|---|---|
| Receipt number | R000065946 |
| Scientific Title | Clinical evaluation of high-frequency intermittent replacement hemodiafiltration |
| Date of disclosure of the study information | 2025/04/26 |
| Last modified on | 2026/04/27 10:06:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical evaluation of high-frequency intermittent replacement hemodiafiltration
Acronym
Clinical evaluation of high-frequency intermittent replacement hemodiafiltration
Scientific Title
Clinical evaluation of high-frequency intermittent replacement hemodiafiltration
Scientific Title:Acronym
Clinical evaluation of high-frequency intermittent replacement hemodiafiltration
Region
| Japan |
Condition
Condition
Patients with end-stage renal failure undergoing postdilution online hemodiafiltration
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying the solute removal performance of high-frequency intermittent replenishment hemodiafiltration using different hemodiafilters
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Removal rate and amount of alfa1-microglobulin, amount of albumin leakage
Key secondary outcomes
Removal rate and amount of urea, creatinine, and phosphorus
Material costs and waste
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
High-frequency intermittent hemodiafiltration with fluid replacement volume of 10.4L and 12.7L will be performed once a week
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing post-dilution hemodiafiltration
Key exclusion criteria
1. Patients who cannot provide written informed consent
2. Patients who are deemed inappropriate by the principal investigator
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Michiwaki |
Organization
Social Medical Corporation Kawashimakai
Division name
Department of Clinical Engineering
Zip code
770-0011
Address
6-1 Kitasakoichibancho, Tokushima City, Tokushima, Japan
TEL
088-631-0110
michiwaki@khg.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Michiwaki |
Organization
Social Medical Corporation Kawashimakai
Division name
Department of Clinical Engineering
Zip code
770-0011
Address
6-1 Kitasakoichibancho, Tokushima City, Tokushima, Japan
TEL
088-631-0110
Homepage URL
michiwaki@khg.or.jp
Sponsor or person
Institute
Social Medical Corporation Kawashimakai
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Social Medical Corporation Kawashimakai Kawashima Hospital
Address
6-1 Kitasakoichibancho, Tokushima City, Tokushima, Japan
Tel
088-631-0110
nekooken@khg.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
社会医療法人川島会脇町川島クリニック（徳島県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5
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
Completed
Date of protocol fixation
| 2025 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 24 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065946
