UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054564 |
|---|---|
| Receipt number | R000062341 |
| Scientific Title | Basic research on the distribution pattern of post-translational modification-variants of urinary erythropoietin |
| Date of disclosure of the study information | 2024/06/04 |
| Last modified on | 2024/06/03 20:25:00 |
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Basic information
Public title
Study on the variation of urinary erythropoietin
Acronym
Study on the variation of urinary erythropoietin
Scientific Title
Basic research on the distribution pattern of post-translational modification-variants of urinary erythropoietin
Scientific Title:Acronym
PTM of uEPO
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain basic data on the distribution pattern of post-translational modification (PTM)-variants of erythropoietin (EPO) found in the urine of healthy people.
Basic objectives2
Others
Basic objectives -Others
Collection of basic data on the degree of individual differences in urinary EPO concentration and distribution pattern of isoelectric variants
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Concentration of erythropoietin
Distribution pattern of isoelectric variants of erythropoietin
Key secondary outcomes
Gender difference
Age difference
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those aged 18 to 59 who do not have any renal or urinary disorders
Key exclusion criteria
Those with kidney or urinary dysfunction
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kobayashi |
Organization
Fukushima Medical University
Division name
Department of Cellular and Integrative Physiology, School of Medicine
Zip code
960-1295
Address
1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295, Japan
TEL
024-547-1128
coba@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kobayashi |
Organization
Fukushima Medical University
Division name
Department of Cellular and Integrative Physiology, School of Medicine
Zip code
960-1295
Address
1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295, Japan
TEL
024-547-1128
Homepage URL
coba@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Daisuke Kobayashi
Funding Source
Organization
World Anti-Doping Agency
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Canada (Headquarters)
Other related organizations
Co-sponsor
ACE BioAnalysis Inc. (The distribution pattern of isoelectric variants of urinary erythropoietin will be measured by ACE BioAnalysis Inc., a research partner institution.)
Name of secondary funder(s)
Part of the testing costs at ACE BioAnalysis Inc. will be covered by a research grant (23B04KS) awarded by the World Anti-Doping Agency (WADA) to Dr. Kiyohito Shimura (CEO of ACE BioAnalysis Inc.).
IRB Contact (For public release)
Organization
Fukushima Medical University General Ethics Committee
Address
1 Hikariga-oka, Fukushima, Fukushima 960-1295, Japan
Tel
024 547 1825
fmurec@fmu.ac.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
福島県立医科大学医学部（福島県）／Fukushima Medical University, School of Medicine (Fukushima),
エースバイオアナリシス株式会社（福島県）／ACE BioAnalysis Inc. (Fukushima)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 04 | 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 | 05 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Measurement of the distribution pattern of isoelectric variants of urinary erythropoietin will be performed by ACE BioAnalysis Inc., a research partner organization. Part of the cost required for this measurement will be covered by a research grant provided by the World Anti-Doping Agency (WADA) to Dr. Kiyohito Shimura (CEO of ACE BioAnalysis Inc.). The title of the research project supported by WADA is "Investigation on the applicability of the direct coupling of immunocapture and capillary isoelectric focusing for EPO analysis in urine samples. (23B04KS)"
Management information
Registered date
| 2024 | Year | 06 | Month | 04 | Day |
Last modified on
| 2024 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062341
