UMIN-CTR Clinical Trial

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
Email	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
Email	moritoki@med.kagawa-u.ac.jp

Sponsor
Institute	Kagawa University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018070