UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016660 |
|---|---|
| Receipt number | 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 | 2022/09/05 12:16:57 |
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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 | MAYUKO |
| Middle name | |
| Last name | HANAI |
Organization
Department of Medicine
Kurume University School of Medicine
Division name
Division fo Nephrology
Zip code
8300011
Address
67, Asahi-machi ,Kurume-shi, Fukuoka, 830-0011, Japan
TEL
0942-35-3311(5346)
hanai_mayuko@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | MAYUKO |
| Middle name | |
| Last name | HANAI |
Organization
Department of Medicine, Kurume University School of Medicine
Division name
Division fo Nephrology
Zip code
8300011
Address
67, Asahi-machi ,Kurume-shi, Fukuoka, 830-0011, Japan
TEL
0942-35-3311(5346)
Homepage URL
nephron@med.kurume-u.ac.jp
Sponsor or person
Institute
Division fo Nephrology,
Department of Medicine,
Kurume University School of Medicine
Institute
Department
Personal name
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
Ethical committee,Kurume University School of Medicine
Address
67, Asahi-machi,
Tel
0942-35-3311(2262)
sangaku@kurume-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
| 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
| 2014 | Year | 05 | Month | 15 | Day |
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
| 2022 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019306
