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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032867
Receipt No. R000014893
Official scientific title of the study Efficacy and safety of sucroferric oxyhydroxide on hemodialysis patients
Date of disclosure of the study information 2018/06/05
Last modified on 2018/06/05

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Basic information
Official scientific title of the study Efficacy and safety of sucroferric oxyhydroxide on hemodialysis patients
Title of the study (Brief title) Efficacy of sucroferric oxyhydroxide on HD
Region
Japan

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

Objectives
Narrative objectives1 To observe the efficay nad safetey of sucroferric oxyhydroxide on hemodialysis patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes FGF23 levels and anemia-related parameters
Key secondary outcomes Ca, P, intact-PTH levels
safety

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Sucroferric oxyhydroxide
Interventions/Control_2 Lanthanum carbohydrate
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
85 years-old >=
Gender Male and Female
Key inclusion criteria (1) age > 19 years and < 86 years, (2) hemodialysis duration >6 months at enrollment, and (3) hyperphosphatemia that was treated with lanthanum carbonate at least 12 weeks before enrollment.
Key exclusion criteria (1) age < 20 years or > 85 years; (2) history of severe heart failure, angina, myocardial infarction, or stroke within the past 6 months; (3) presence of infectious disease, malignant tumors, or treatment with steroids or immunosuppressants; (4) current hospitalization; and (5) treatment with ferric citrate hydrate within the past 6 months.
Target sample size 60

Research contact person
Name of lead principal investigator Masanori Abe
Organization Nihon University School of Medicine
Division name Nephrology, Hypertension and Endocrinology
Address 30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Email abe.masanori@nihon-u.ac.jp

Public contact
Name of contact person Tomoyasu Otsuki
Organization Nihon University School of Medicine
Division name Nephrology, Hypertension and Endocrinology
Address 30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Homepage URL
Email totsuki16@gmail.com

Sponsor
Institute Department of Nephrology, hypertension and Endocrinology, Nihon University School of Medicine
Institute
Department

Funding Source
Organization Nephrology, Hypertension and Endocrinology, Nihon University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 06 Month 05 Day

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 08 Month 31 Day
Anticipated trial start date
2016 Year 01 Month 06 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 03 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 05 Day
Last modified on
2018 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014893

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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