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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019305
Receipt No. R000022326
Scientific Title Dynamics of iron status in chronic hemodialysis patients -measurement of iron loss and periodic supplementation-
Date of disclosure of the study information 2015/10/09
Last modified on 2016/11/06

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Basic information
Public title Dynamics of iron status in chronic hemodialysis patients
-measurement of iron loss and periodic supplementation-
Acronym Dynamics of iron status in chronic hemodialysis patients
Scientific Title Dynamics of iron status in chronic hemodialysis patients
-measurement of iron loss and periodic supplementation-
Scientific Title:Acronym 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
1st name
Middle name
Last name Tatsuo Tsukamoto
Organization Kyoto University Hospital
Division name Department of nephrology
Zip code
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
1st name
Middle name
Last name Tatsuo Tsukamoto
Organization Kyoto University Hospital
Division name Department of nephrology
Zip code
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)

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 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

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
Annual iron loss by hemodialysis is around 500mg in Japan. (Am J Nephrol. 2016;43(1):32-8)
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
2015 Year 03 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000022326

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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