UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of iron supplementation methods for hemodialysis patients
Title of the study (Brief title)	Comparison of iron supplementation methods for hemodialysis patients
Region	Japan

Condition
Condition	end-stage kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy and safety of intravenous and oral iron supplementation in hemodialysis patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in hemoglobin values of before and after the iron supplementation and the frequency of side effect by iron supplementation
Key secondary outcomes	Changes in values of serum iron, transferrin saturation, ferritin, and the amount of administered erythropoiesis-stimulating agents

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravenous administration of 40mg of saccharated ferric oxide once a week after hemodialysis
Interventions/Control_2	Oral administration of 50-100mg of sodium ferrous citrate per day
Interventions/Control_3	Ferric citrate hydrate group: oral administration of 500-2250mg of ferric citrate hydrate per day irrespective of iron deficiency [In this group, only patients with hyperphosphatemia (serum phosphate >6.0mg/dL) are registered.]
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Hemodialysis patients complicated with iron deficiency (transferrin saturation < 20% and ferritin < 100 ng/mL) or hyperphosphatemia
Key exclusion criteria	Patients complicated with potential diseases causing anemia such as hemorrhagic disease, hematological disease, or carcinoma
Target sample size	300

Research contact person
Name of lead principal investigator	Michio Kuwahara
Organization	Shuuwa General Hospital
Division name	Department of Nephrology
Address	1200 Yahara-Shinden, Kasukabe, Saitama 344-0035, Japan
TEL	048-737-2121
Email	kuwaharam@shuuwa-gh.or.jp

Public contact
Name of contact person	Michio Kuwahara
Organization	Shuuwa General Hospital
Division name	Department of Nephrology
Address	1200 Yahara-Shinden, Kasukabe, Saitama 344-0035, Japan
TEL	048-737-2121
Homepage URL
Email	kuwaharam@shuuwa-gh.or.jp

Sponsor
Institute	Shuuwa General Hospital
Institute
Department

Funding Source
Organization	Shuuwa General Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2015 Year 05 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 10 Month 27 Day
Anticipated trial start date	2014 Year 11 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This research had been planned and promoted by Michio Kuwahara (MK). However, MK was transferred to work in April 2017, and MK currently work for another hospital. MK wss unable to find a researcher who will take over this research. Therefore, MK had to abandon the continuation of this research.

Management information
Registered date	2015 Year 05 Month 01 Day
Last modified on	2018 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020152