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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010730
Receipt No. R000012538
Scientific Title Effect of lanthanum carbonate on serum levels of calcification inhibitor fetuin-A in hemodialysis patients
Date of disclosure of the study information 2013/05/15
Last modified on 2018/11/19

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Basic information
Public title Effect of lanthanum carbonate on serum levels of calcification inhibitor fetuin-A in hemodialysis patients
Acronym Effect of lanthanum carbonate on serum levels of fetuin-A in hemodialysis patients
Scientific Title Effect of lanthanum carbonate on serum levels of calcification inhibitor fetuin-A in hemodialysis patients
Scientific Title:Acronym Effect of lanthanum carbonate on serum levels of fetuin-A in hemodialysis patients
Region
Japan

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

Objectives
Narrative objectives1 This study is designed to investigate the effect of lanthanum carbonate treatment on serum fetuin-A concentrations in hemodialyasis patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes serum fetuin-A concentration
Key secondary outcomes serum FGF-23 concentration
safety evaluation

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Lanthanum carbonate 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
85 years-old >
Gender Male and Female
Key inclusion criteria Hemodialysis patient
Hyperphosphatemia patient
Key exclusion criteria Lanthanum carbonate contraindication
After parathyroidectomy
Peritoneal dialysis patient
Digestive tract disease patient
Liver dysfunction patient
Pregnant woman

Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name hideyasu matsuyama
Organization Yamaguchi university
Division name Department of urology
Zip code
Address 1-1-1,minamikogushi , ube city, yamaguchi prefer,japan
TEL 0836-22-2275
Email hidde@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideyasu Matsuyama
Organization Yamaguchi University Hospital
Division name Department of urology
Zip code
Address Ube
TEL 0836222275
Homepage URL
Email hidde@yamaguchi-u.ac.jp

Sponsor
Institute Department of urology, school of medicine,yamaguchi university
Institute
Department

Funding Source
Organization Bayer health care
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
2013 Year 05 Month 15 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
2013 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 15 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
2013 Year 05 Month 15 Day
Last modified on
2018 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012538

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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