UMIN-CTR Clinical Trial

Basic information
Public title	Effect of ferric citrate for recovery from fatigue, phosphate binding, and iron supplementation in hemodialysis patients with well-controlled parathyroid hormone. -comparison with lanthanum carbonate-
Acronym	Effect of ferric citrate for recovery from fatigue, phosphate binding capacity, and iron supplementation.
Scientific Title	Effect of ferric citrate for recovery from fatigue, phosphate binding, and iron supplementation in hemodialysis patients with well-controlled parathyroid hormone. -comparison with lanthanum carbonate-
Scientific Title:Acronym	Effect of ferric citrate for recovery from fatigue, phosphate binding capacity, and iron supplementation.
Region	Japan

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

Objectives
Narrative objectives1	To verify the effect of ferric citrate for recovery from fatigue.
Basic objectives2	Others
Basic objectives -Others	To evaluate the phosphate binding efficacy of ferric citrate.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The ammount of fatigue score change in questionnaire consisted of 64 questions at 2weeks after administartion of ferric citrate or lanthum carbonate.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	intervention: ferric citrate 1500 mg/day, 3 months
Interventions/Control_2	control: lanthanum carbonate 1500 mg/day, 3 months
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)Hemodialysis patients 2)TSAT < 20 % and serum ferritin < 100 ng/mL 3)Serum intact-PTH 60-240 pg/mL 4)Hb 9.0-11.5 g/dL 5)Serum phosphate >6.0 mg/dL or taking phosphate binders except for ferric citrate and Sucroferric oxyhydroxide.
Key exclusion criteria	1)taking iron medication 2)malignancy, severe sepsis 3)gastrointestinal hemorrge 4)pregnant or possible pregnancy 5)Allergy to ferric citrate or lanthunum carbonate 6)Inappropriate patients regarded by doctor.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yu Middle name Last name Tateishi
Organization	Ishikiri Seiki Hospital
Division name	Department of Nephrology
Zip code	5798026
Address	18-28, yahoi-cho, Higasi-Osaka city, Osaka, Japan
TEL	072-988-3121
Email	y-tateishi@ishikiriseiki.or.jp

Public contact
Name of contact person	1st name Yu Middle name Last name Tateishi
Organization	Ishikiri Seiki Hospital
Division name	Department of Nephrology
Zip code	579-8026
Address	18-28, yahoi-cho, Higasi-Osaka city, Osaka, Japan
TEL	072-988-3121
Homepage URL
Email	y-tateishi@ishikiriseiki.or.jp

Sponsor
Institute	Ishikiri Seiki Hospital
Institute
Department

Funding Source
Organization	SB bioscience co. ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ishikiriseiki Hospital Institutional review board
Address	18-28, yahoi-cho, Higasi-Osaka city, Osaka, Japan
Tel	072-988-3121
Email	webmaster@ishikiriseiki.or.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

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 13 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	Open public recruiting
Date of protocol fixation	2018 Year 11 Month 30 Day
Date of IRB	2019 Year 11 Month 22 Day
Anticipated trial start date	2020 Year 03 Month 13 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 12 Day
Last modified on	2020 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040002