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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016660
Receipt No. R000019306
Scientific Title The clinical survey of prognosis and evaluation of treatment regimen in IgA Nephropathy diagnosed in Kurume University Hospital.
Date of disclosure of the study information 2015/03/15
Last modified on 2018/08/30

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Basic information
Public title The clinical survey of prognosis and evaluation of treatment regimen in IgA Nephropathy diagnosed in Kurume University Hospital.
Acronym The clinical survey of prognosis and evaluation of treatment regimen in IgA Nephropathy diagnosed in Kurume University Hospital.
Scientific Title The clinical survey of prognosis and evaluation of treatment regimen in IgA Nephropathy diagnosed in Kurume University Hospital.
Scientific Title:Acronym The clinical survey of prognosis and evaluation of treatment regimen in IgA Nephropathy diagnosed in Kurume University Hospital.
Region
Japan

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

Objectives
Narrative objectives1 Our aim is to investigate the treatment effect according to our IgA Nephropathy(IgA-N) score and prognosis of IgA-N diagnosed by renal biopsy and in Kurume University Hospital.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We checked eGFR, protein urin, microscopic hematuria, dialysis and death after 2 years and 4 years of renal biopsy, and at the end of the follow-up period.
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
12 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Only patients with IgA Nephropathy diagnosed by renal biopsy in our hospital.
Key exclusion criteria Directors of the hospitals do not allow us to collect clinical data.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name MAYUKO HANAI
Organization Department of Medicine
Kurume University School of Medicine
Division name Division fo Nephrology
Zip code
Address 67, Asahi-machi ,Kurume-shi, Fukuoka, 830-0011, Japan
TEL 0942-35-3311(5346)
Email hanai_mayuko@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name MAYUKO HANAI
Organization Department of Medicine, Kurume University School of Medicine
Division name Division fo Nephrology
Zip code
Address 67, Asahi-machi ,Kurume-shi, Fukuoka, 830-0011, Japan
TEL 0942-35-3311(5346)
Homepage URL
Email nephron@med.kurume-u.ac.jp

Sponsor
Institute Division fo Nephrology,
Department of Medicine,
Kurume University School of Medicine
Institute
Department

Funding Source
Organization Division fo Nephrology,
Department of Medicine,
Kurume University School of Medicine
Organization
Division
Category of Funding Organization Other
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
2015 Year 03 Month 15 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 No longer recruiting
Date of protocol fixation
2014 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 15 Day
Last follow-up date
2014 Year 09 Month 30 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information Retrospective study

Management information
Registered date
2015 Year 02 Month 27 Day
Last modified on
2018 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019306

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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