UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015551 |
|---|---|
| Receipt number | R000018070 |
| Scientific Title | Study of galectin-9 as novel biomarker of activity and therapeutic agent in IgA nephropathy |
| Date of disclosure of the study information | 2014/11/11 |
| Last modified on | 2019/11/13 20:04:45 |
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Basic information
Public title
Study of galectin-9 as novel biomarker of activity and therapeutic agent in IgA nephropathy
Acronym
Study of galectin-9 as novel biomarker of activity and therapeutic agent in IgA nephropathy
Scientific Title
Study of galectin-9 as novel biomarker of activity and therapeutic agent in IgA nephropathy
Scientific Title:Acronym
Study of galectin-9 as novel biomarker of activity and therapeutic agent in IgA nephropathy
Region
| Japan |
Condition
Condition
IgA nephropathy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prognosis value of plasma and urinary galectin-9 concentrations for activity and treatment reactivity of patient with IgA nephropathy
Basic objectives2
Others
Basic objectives -Others
disease activity of IgA nephropathy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary protein, hematuria, serum creatinine, estimated GFR, histological findings
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
| 16 | 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 will receive the tonsillectomy and steroid therapy.
Patients who agree to participate in the study.
Key exclusion criteria
Patients under age 16 and over 80.
Patients who do not agree to participate in the study.
Patients decided by the doctor to be unsuitable to the study other than above.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Moritoki |
Organization
Kagawa University Hospital
Division name
Department of nephrology
Zip code
761-0793
Address
1750-1 Ikenobe, Mikityou, Kitagun, Kagawa-ken JAPAN
TEL
087-891-2149
moritoki@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Moritoki |
Organization
Kagawa University Hospital
Division name
Department of nephrology
Zip code
761-0793
Address
1750-1 Ikenobe, Mikityou, Kitagun, Kagawa-ken JAPAN
TEL
087-891-2149
Homepage URL
moritoki@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa University School of Medicine Ethics Committee
Address
1750-1 Ikenobe, Mikityou, Kitagun, Kagawa-ken JAPAN
Tel
087-898-5111
chiken-b.@med.kagawa-u.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
| 2014 | Year | 11 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Predictive variable: galectin-9
Outcome: disease activity and treatment reactivity of IgA nephropathy
Management information
Registered date
| 2014 | Year | 10 | Month | 28 | Day |
Last modified on
| 2019 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018070
