UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061335 |
|---|---|
| Receipt number | R000070131 |
| Scientific Title | Changes in solute removal performance due to changes in dialysate flow rate settings |
| Date of disclosure of the study information | 2026/04/21 |
| Last modified on | 2026/04/21 14:29:59 |
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Basic information
Public title
Changes in solute removal performance due to changes in dialysate flow rate settings
Acronym
Changes in solute removal performance due to changes in dialysate flow rate settings
Scientific Title
Changes in solute removal performance due to changes in dialysate flow rate settings
Scientific Title:Acronym
Changes in solute removal performance due to changes in dialysate flow rate settings
Region
| Japan |
Condition
Condition
Patients with end-stage renal failure exhibiting malnutrition with serum albumin levels below 3.0 g/dl.
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the conditions for dialysis treatment according to the pathological condition of patients with end-stage renal failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Standardized Kt/V
Key secondary outcomes
Removal rates and amounts of urea, creatinine, phosphate,beta2-microglobulin,and alpha1-microglobulin; blood gas analysis; albumin leakage; post-dialysis fatigue (PDF); and dialysis recovery time (DRT).
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
Dialysis fluid volume change intervention
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
1. Patients exhibiting malnutrition with serum albumin levels below 3.0 g/dl
2. Patients who can maintain a stable blood flow rate of 250 ml/min or more during treatment
Key exclusion criteria
1. Patients who are deemed inappropriate by the principal investigator
2. Patients who cannot provide written informed consent
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Michiwaki |
Organization
Kawashima Hospital
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
Kawashima Hospital
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
Kawashima Hospital
Institute
Department
Personal name
Funding Source
Organization
Kawashima Hospital
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
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 21 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 21 | 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
Management information
Registered date
| 2026 | Year | 04 | Month | 21 | Day |
Last modified on
| 2026 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070131
