UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011414 |
|---|---|
| Receipt number | 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 12:48:34 |
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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
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
yusuke@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Facility of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013365
