UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030669 |
|---|---|
| Receipt number | R000035014 |
| Scientific Title | Comparison of removal efficacy of blood nucleic acids, phenol derivatives, xanthine derivatives and the mitochondrial functional marker in hemodialysis and online hemodiafiltration |
| Date of disclosure of the study information | 2018/01/14 |
| Last modified on | 2019/08/25 14:37:00 |
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Basic information
Public title
Comparison of removal efficacy of blood nucleic acids, phenol derivatives, xanthine derivatives and the mitochondrial functional marker in hemodialysis and online hemodiafiltration
Acronym
Comparison of removal efficacy of blood nucleic acids, phenol derivatives, xanthine derivatives and the mitochondrial functional marker in hemodialysis and online hemodiafiltration
Scientific Title
Comparison of removal efficacy of blood nucleic acids, phenol derivatives, xanthine derivatives and the mitochondrial functional marker in hemodialysis and online hemodiafiltration
Scientific Title:Acronym
Comparison of removal efficacy of blood nucleic acids, phenol derivatives, xanthine derivatives and the mitochondrial functional marker in hemodialysis and online hemodiafiltration
Region
| Japan |
Condition
Condition
dialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the removal efficacy of blood nucleic acids, phenol derivatives, xanthine derivatives and mitochondrial functional markers in hemodialysis and online hemodiafiltration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The reduction ratio and total solute removal of blood nucleic acids (1-Methyladenosine, etc) and phenol derivatives (indoxylsulphate, p-cresylsulphate, etc) in hemodialysis and online hemodiafiltration.
Key secondary outcomes
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
| Other |
Interventions/Control_1
We change the dialysis method such as the hemodialysis, the pre-dilution hemodiafiltration and the post-dilution hemodiafiltration.
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
Stable chronic maintenance dialysis patients.
Key exclusion criteria
The patient who uses blood purification except for hemodialysis or hemodiafiltration together.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisato Shima |
Organization
Kawashima hospital
Division name
Department of Kidney Disease
Zip code
Address
1-39 Kitasakoichiban-cho, Tokushima city 770-0011, Tokushima, Japan
TEL
088-631-0110
h.shima@khg.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisato Shima |
Organization
Kawashima hospital
Division name
Department of Kidney Disease
Zip code
Address
1-39 Kitasakoichiban-cho, Tokushima city 770-0011, Tokushima, Japan
TEL
088-631-0110
Homepage URL
h.shima@khg.or.jp
Sponsor or person
Institute
Kawashima Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 01 | Month | 14 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2018 | Year | 01 | Month | 04 | Day |
Last modified on
| 2019 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035014
