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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011414
Receipt No. R000013365
Scientific Title The clarification of the pathological role of CX3CR1/fractalkine/AIM axis in IgA nephropathy
Date of disclosure of the study information 2013/08/12
Last modified on 2014/08/08

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Basic information
Public title The clarification of the pathological role of CX3CR1/fractalkine/AIM axis in IgA nephropathy
Acronym Clarification of the association between disease activity of IgA nephropathy and CX3CR1/fractalkine/AIM expression, and its pathological role.
Scientific Title The clarification of the pathological role of CX3CR1/fractalkine/AIM axis in IgA nephropathy
Scientific Title:Acronym Clarification of the association between disease activity of IgA nephropathy and CX3CR1/fractalkine/AIM expression, and its pathological role.
Region
Japan

Condition
Condition IgA nephropathy
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analysis for the association between the expression of CX3CR1 in monocytes and disease activity of IgA nephropathy.
Basic objectives2 Others
Basic objectives -Others disease activity of IgA nephropathy
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Hematuria, urinary protein, serum creatinine, estimated GFR
Key secondary outcomes

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 Prevention
Type of intervention
Maneuver
Interventions/Control_1 Collect 3ml of blood and urine samples additionally at routine examinations.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who have been diagnosed with IgA nephropathy by renal biopsy
Patients who have not received the tonsillectomy or steroid therapy.
Patients who agree to participate in the study.
Key exclusion criteria Patients who will transfer to another hospital during the treatment.
Patients who already had tonsillectomy or steroid therapy.
Patients who already have started immunosuppressant therapy.
Patients decided by the doctor to be unsuitable to the study other than above.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke Suzuki
Organization Juntendo University
Division name Division of Nephrology, Department of Internal Medicine
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL 03-5802-1065
Email yusuke@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Suzuki
Organization Juntendo University
Division name Division of Nephrology, Department of Internal Medicine
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL 03-5802-1065
Homepage URL
Email yusuke@juntendo.ac.jp

Sponsor
Institute Juntendo University, Facility of Medicine
Institute
Department

Funding Source
Organization none
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
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 08 Month 12 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 07 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 12 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 08 Month 07 Day
Last modified on
2014 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013365

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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