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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023700
Receipt No. R000027276
Scientific Title Effect of iron containing phosphate binder on iron metabolism of patients undergoing maintenance hemodialysis.
Date of disclosure of the study information 2016/10/01
Last modified on 2016/08/20

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Basic information
Public title Effect of iron containing phosphate binder on iron metabolism of patients undergoing maintenance hemodialysis.
Acronym Effect of iron containing phosphate binder on iron metabolism of patients undergoing maintenance hemodialysis.
Scientific Title Effect of iron containing phosphate binder on iron metabolism of patients undergoing maintenance hemodialysis.
Scientific Title:Acronym Effect of iron containing phosphate binder on iron metabolism of patients undergoing maintenance hemodialysis.
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is the evaluation for the effectiveness, safety, and the effect on anemia, iron, CKD-MBD related factors of iron containing phosphate binder.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse events (cerebral cardiovascular disease, infection, hospitalization) and survival.
Key secondary outcomes The effect of iron containing phosphate binder on the anemia (Hb, Ret, RDW,dose of iron and ESA), iron metabolism(ferritin, TSAT, hepcidin, NTBI), CKD-MBD(Ca, P, FGF23,dose of phosphate binder, vitaminD, cinacalcet), arteriosclerosis (PWV, ABI, TMAO, LVMI), and microbiome.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are 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 According to the clinical practice guideline for the management of chronic kidney disease-mineral and bone disorder (JSDT 2012), treated with iron containing phosphate binder for 3 year.
Interventions/Control_2 According to the clinical practice guideline for the management of chronic kidney disease-mineral and bone disorder (JSDT 2012),treated with non iron containing phosphate binder for 3 year.
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 Maintenance hemodialysis patient with high serum phosphate level.
Key exclusion criteria 1) Patients who received maintenance hemodialysis for < 6month.
2) Patients with severe heart failure (>NYHA III), respiratory failure, malignancy disease, or severe liver dysfunction.
3) Patient with high serum ferritin level(>100 ng/mL) at the start of this study.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Nakanishi
Organization Hyogo College of Medicine
Division name Department of Internal Medicine, Division of Kidney and dialysis
Zip code
Address 1-1, Mukogawa cho, Nishinomiya
TEL 0798-45-6521
Email jin@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Kuragano
Organization Hyogo College of Medicine
Division name Department of Internal Medicine, Division of Kidney and dialysis
Zip code
Address 1-1, Mukogawa cho, Nishinomiya
TEL 0798-45-6521
Homepage URL
Email kuragano@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Kissei Pharmaceutical 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
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
2016 Year 10 Month 01 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
Date of protocol fixation
2016 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 10 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
2016 Year 08 Month 20 Day
Last modified on
2016 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027276

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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