UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dynamics of iron status in chronic hemodialysis patients -measurement of iron loss and periodic supplementation-
Title of the study (Brief title)	Dynamics of iron status in chronic hemodialysis patients
Region	Japan

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

Objectives
Narrative objectives1	Safety and efficacy of iron supplementation equivalent to iron loss by hemodialysis procedure
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	annual iron status
Key secondary outcomes	hemoglobin, serum iron, transferrin satulation rate, ferritin, dose of erythropoiesis stumulating agent

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	periodic iron supplementation for one year
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	18 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	chronic hemodialysis patients
Key exclusion criteria	1) active malignancy, hematological disorder, iron looser by gastro-intestinal bleeding, etc. 2) allergy against ESA 3) pregnant or considering pregnanct woman, lactating woman 4) patients attending other clinical trials 5) improper patien
Target sample size	250

Research contact person
Name of lead principal investigator	Tatsuo Tsukamoto
Organization	Kyoto University Hospital
Division name	Department of nephrology
Address	54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL	+81-75-751-3860
Email	ttsukamo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Tatsuo Tsukamoto
Organization	Kyoto University Hospital
Division name	Department of nephrology
Address	54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL	+81-75-751-3860
Homepage URL
Email	ttsukamo@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Deaprtment of nephrology, Kyoto University Hospital
Institute
Department

Funding Source
Organization	Deaprtment of nephrology, Kyoto University 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	洛和会音羽記念病院

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 04 Month 30 Day
Date trial data considered complete	2017 Year 04 Month 30 Day
Date analysis concluded	2017 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	Annual iron loss by hemodialysis is around 500mg in Japan. (Am J Nephrol. 2016;43(1):32-8)
Other related information

Management information
Registered date	2015 Year 10 Month 09 Day
Last modified on	2016 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022326