UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054861 |
|---|---|
| Receipt number | R000062686 |
| Scientific Title | Solute removal characteristics in hemodialysis patients. |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/01/03 09:39:13 |
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Basic information
Public title
Solute removal characteristics in hemodialysis patients.
Acronym
Solute removal removal in hemodialysis patients
Scientific Title
Solute removal characteristics in hemodialysis patients.
Scientific Title:Acronym
Solute removal characteristics in hemodialysis patients.
Region
| Japan |
Condition
Condition
hemodialysis patient
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observing substance concentrations over time during dialysis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes over time from the start of dialysis to the end of dialysis.
Removal rate and removal of indoxyl sulphate and alpha-1MG, albumin leakage, free fatty acids and BUN, Ratio of oxidised to reduced albumin.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Dialysis patients with stable hemodialysis
Patients with serum albumin > 3.0 g/dl
Key exclusion criteria
Patients unable to give consent.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Tashiro |
Organization
Kawashima hospital
Division name
nephrology
Zip code
770-0011
Address
Kawashima Hospital, 6-1 Kitasakoichiban-Cho, Tokushima-City
TEL
088-631-0110
m.tashiro@khg.or.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Tashiro |
Organization
Kawashima hospital
Division name
nephrology
Zip code
nephrology
Address
Kawashima Hospital, 6-1 Kitasakoichiban-Cho, Tokushima-City
TEL
088-631-0110
Homepage URL
m.tashiro@khg.or.jp
Sponsor or person
Institute
Kawashima hospital
Institute
Department
Personal name
Funding Source
Organization
Tsuchiya Memorial Medical Promotion Fund
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawashima hospital
Address
Kawashima Hospital, 6-1 Kitasakoichiban-Cho, Tokushima-City
Tel
0886310110
m.tashiro@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
| 2024 | Year | 08 | Month | 01 | 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
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 01 | Day |
Other
Other related information
Pre-OHDF is planned for dialysis conditions.
Management information
Registered date
| 2024 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062686
