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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008351
Receipt No. R000009462
Scientific Title The effect of Kremezin to klotho
Date of disclosure of the study information 2012/07/04
Last modified on 2012/07/04

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Basic information
Public title The effect of Kremezin to klotho
Acronym The effect of Kremezin to klotho
Scientific Title The effect of Kremezin to klotho
Scientific Title:Acronym The effect of Kremezin to klotho
Region
Japan

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

Objectives
Narrative objectives1 The effect of Kremezin to klotho
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The change of klotho
Key secondary outcomes 1.indoxyl sulfate
2.serum creatinine
3.the retio of urine protein/urine creatinine
4.cystatine C

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 control
observation period 2 years
Interventions/Control_2 additional internal use of kremezin 6g/day
observation period 2years
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
74 years-old >=
Gender Male and Female
Key inclusion criteria 20 years old and over
patients of chronic kidney disease( 1.5mg/dL and over sCr 5mg/dL and fewer, and e-GFR 60ml/min./1.73m2 and fewer)
Key exclusion criteria patients of
1.75 years old and over
2.diabetic kidney disease
3.gastrointestinal obstruction
4.poor control of hypertension
5.internal use of ESA or will use of ESA
6.principal investigator dicide to be unsuitable testee
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kosaku Nitta
Organization Tokyo women's medical university
Division name Department of medicine four
Zip code
Address 8-1Kawadacho, Shinjuku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shunji Shiohira
Organization Tokyo women's medical university
Division name Department of medicine four
Zip code
Address 8-1Kawadacho, Shinjuku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Tokyo women's medical university
Institute
Department

Funding Source
Organization Tokyo women's medical university
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 東京女子医科大学

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 04 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 Enrolling by invitation
Date of protocol fixation
2012 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2014 Year 06 Month 01 Day
Date of closure to data entry
2014 Year 07 Month 01 Day
Date trial data considered complete
2014 Year 07 Month 01 Day
Date analysis concluded
2014 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 07 Month 04 Day
Last modified on
2012 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009462

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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