UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031406 |
|---|---|
| Receipt number | R000035858 |
| Scientific Title | Clinical study on iron absorption after oral administration of ferric citrate hydrate - Riona-Oral Iron Absorption Trial (R-OIAT)- |
| Date of disclosure of the study information | 2018/02/21 |
| Last modified on | 2022/02/18 17:08:48 |
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Basic information
Public title
Clinical study on iron absorption after oral administration of ferric citrate hydrate - Riona-Oral Iron Absorption Trial (R-OIAT)-
Acronym
R-OIAT
Scientific Title
Clinical study on iron absorption after oral administration of ferric citrate hydrate - Riona-Oral Iron Absorption Trial (R-OIAT)-
Scientific Title:Acronym
R-OIAT
Region
| Japan |
Condition
Condition
Hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association with serum hepcidine-25 and absorption of iron
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) serum Hepcidine-25
2) serum iron
(first visit, 3month, 6month)
Key secondary outcomes
1) UIBC
2) serum ferritin
( first visit, 3month, 6month)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Maintenance hemodialysis patients
2) Given informed consent
3) Agree to contraception during the study
Key exclusion criteria
1) infectious disease
2) malignancy
3) pregnancy
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohisa Tomosugi |
Organization
Kanazawa Medical University
Division name
Medical Research Institute , Division of Systems Bioscience for Drug Discovery Based on Intrinsically Disordered Proteins
Zip code
Address
1-1 Daigaku, Uchinaka-machi, Kahoku-gun, Ishikawa-ken 920-0293, Japan
TEL
076-286-2211
tomosugi@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohisa Tomosugi |
Organization
Kanazawa Medical University
Division name
Medical Research Institute , Division of Systems Bioscience for Drug Discovery Based on Intrinsicall
Zip code
Address
1-1 Daigaku, Uchinaka-machi, Kahoku-gun, Ishikawa-ken 920-0293, Japan
TEL
076-286-2211
Homepage URL
tomosugi@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
TORII PHARMACEUTICAL CO., LTD.
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 | 02 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Hemodialysis patients who initiate ferric citrate hydrate or under treatment with ferric citrate hydrate after meal will be enrolled. Patients will be treated with ferric citrate hydrate after the start of a hemodialysis session on first visit, 3 month and 6 month.
Management information
Registered date
| 2018 | Year | 02 | Month | 21 | Day |
Last modified on
| 2022 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035858
