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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022935
Receipt No. R000026433
Scientific Title The usage survey of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.
Date of disclosure of the study information 2016/07/01
Last modified on 2019/07/01

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Basic information
Public title The usage survey of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.
Acronym The usage survey of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.
Scientific Title The usage survey of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.
Scientific Title:Acronym The usage survey of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.
Region
Japan

Condition
Condition CKD-MBD in hemodialysis patients
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To weigh the usage of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The achievement rate of serum phosphate value.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All cases investigation
Key exclusion criteria Nothing
Target sample size 3600

Research contact person
Name of lead principal investigator
1st name Hirokazu
Middle name
Last name Okada
Organization Saitama Medical University
Division name Department of Nephrology
Zip code 350-0451
Address 38 Morohongo, Moroyama-machi, Irumagun Saitama 350-0495, Japan
TEL 049-276-1611
Email hirookda@saitama-med.ac.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Amano
Organization Saitama Medical University
Division name Department of Nephrology
Zip code 350-0451
Address 38 Morohongo, Moroyama-machi, Irumagun Saitama 350-0495, Japan
TEL 049-276-1611
Homepage URL
Email hiama@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saitama Medical University
Address 38 Morohongo, Moroyama-machi, Irumagun Saitama 350-0495, Japan
Tel 049-276-1111
Email hirb@saitama-med.ac.jp

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 07 Month 01 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/30783915
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/30783915
Number of participants that the trial has enrolled 1373
Results
The median serum phosphorus, corrected calcium and intact PTH for April 2015 were 5.4 mg / dL, 9.1 mg / dL and 147 pg / dL, respectively. In addition,more PB types were significantly correlated with higher serum phosphorus levels (p < 0.001). Compared with other agents, significant change was observed only in FeC group, and serum phosphorus decreased by 0.6 mg / dL (N = 39, p = 0.006). Furthermore, in the same group, hemoglobin increased from 10.4 mg / dL to 11.4 mg / dL (p = 0.002).
Results date posted
2019 Year 07 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Hemodialysis patients in dialysis facilities in western Saitama
Participant flow
Of the 54 facilities, 25 facilities participated. 1641 cases were entered, but 1373 cases were finally entered in the test from exclusion criteria.
Adverse events
non
Outcome measures
We evaluated the basic data of western Saitama dialysis patients and compared the changes in serum phosphorus levels when one new phosphate binder was additionally administered.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 06 Month 06 Day
Date of IRB
2016 Year 06 Month 06 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2017 Year 04 Month 30 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

Other
Other related information nothing

Management information
Registered date
2016 Year 06 Month 28 Day
Last modified on
2019 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026433

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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