UMIN-CTR Clinical Trial

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
Email	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
Email	tomosugi@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University
Institute
Department

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
Email

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035858