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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026308
Receipt No. R000030211
Scientific Title Effect of monthly administration of 40mg saccharated ferric oxide on hemoglobin variability and erythropoiesis resistance index in patients with hemodialysis
Date of disclosure of the study information 2021/03/31
Last modified on 2017/02/25

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Basic information
Public title Effect of monthly administration of 40mg saccharated ferric oxide on hemoglobin variability and erythropoiesis resistance index in patients with hemodialysis
Acronym Hb variability and ERI by monthly administration of iron in HD patients
Scientific Title Effect of monthly administration of 40mg saccharated ferric oxide on hemoglobin variability and erythropoiesis resistance index in patients with hemodialysis
Scientific Title:Acronym Hb variability and ERI by monthly administration of iron in HD patients
Region
Japan

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

Objectives
Narrative objectives1 Stabilization of iron status and erythropoietin resistance index by monthly administration of 40mg saccharated ferric oxide
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Hemoglobin variability
Key secondary outcomes 1)erythropoiesis resistance index
2)Iron deficiency
3)iron exccess

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 monthly iron administration
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1.Clinically stable HD patients with renal anemia more than 1 year
2.Written informed consent was obtained
Key exclusion criteria 1. Iron deficiency
2. Vitamin B12 and/or folate deficiency
3. Unstable iron metabolism
4. Drug allergy
5. Written informed consent was not obtained
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuo Tsukamoto
Organization Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name Neohrology & Dialysis
Zip code
Address 2-4-20 Ohgimachi, Kita-ku, Osaka
TEL 06-6312-8824
Email t-tsukamoto@kitano-hp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuo Tsukamoto
Organization Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name Neohrology & Dialysis
Zip code
Address 2-4-20 Ohgimachi, Kita-ku, Osaka
TEL 06-6312-8824
Homepage URL
Email t-tsukamoto@kitano-hp.or.jp

Sponsor
Institute Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department

Funding Source
Organization Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 31 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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 25 Day
Last modified on
2017 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030211

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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