UMIN-CTR Clinical Trial

Basic information
Public title	Effects and safety of ferric citrate hydrate in patients with receiving hemodialysis.
Acronym	Effects and safety of ferric citrate hydrate in patients with receiving hemodialysis.
Scientific Title	Effects and safety of ferric citrate hydrate in patients with receiving hemodialysis.
Scientific Title:Acronym	Effects and safety of ferric citrate hydrate in patients with receiving hemodialysis.
Region	Japan

Condition
Condition	Chronic hemodialysis patients
Classification by specialty	Nephrology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effects and safety of ferric citrate hydrate in patients with receiving hemodialysis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum P level , control of anemia, and side effects.
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	Medicine
Interventions/Control_1	Serum P level , control of anemia, and side effects.
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	Hemodialysis patients with hyperphosphatamia,over 6mg/dl. Treating with erythropoietin. Serum ferritin less than 300ng/ml. Written informed consent.
Key exclusion criteria	AST,ALT over100 IU/L. Allergy to riona. Pregnant or possible pregnancy. Inappropriate patients regarded by doctor.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Oyama Satoko
Organization	Tomei-Atsugi Hospital
Division name	Nephrology/endocrine.metabolism
Zip code
Address	232 Funako, Atsugi-city, Kanagawa 243-8571
TEL	046-229-1771
Email	satokomonchi@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Oyama Satoko
Organization	Tomei-Atsugi Hospital
Division name	Nephrology/endocrine.metabolism
Zip code
Address	232 Funako, Atsugi-city, Kanagawa 243-8571
TEL	046-229-1771
Homepage URL
Email	satokomonchi@gmail.com

Sponsor
Institute	Tomei-Atsugi Hospital
Institute
Department

Funding Source
Organization	Tomei-Atsugi Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kanazawa Medical University, Division of Systems Bioscience for Drug Discovery Based on Intrinsically Disordered Proteins
Name of secondary funder(s)

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	2017 Year 08 Month 21 Day

Related information
URL releasing protocol
Publication of results	Partially published

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 03 Month 09 Day
Date of IRB	2015 Year 08 Month 10 Day
Anticipated trial start date	2017 Year 04 Month 07 Day
Last follow-up date	2018 Year 08 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	2017 Year 08 Month 15 Day
Last modified on	2022 Year 02 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032823