UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033077 |
|---|---|
| Receipt number | R000037704 |
| Scientific Title | The supplementary analysis to improve optimal and precision therapy of glomerulonephritis |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2021/05/26 10:15:48 |
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Basic information
Public title
The supplementary analysis to improve optimal and precision therapy of glomerulonephritis
Acronym
SUPPORT GN study
Scientific Title
The supplementary analysis to improve optimal and precision therapy of glomerulonephritis
Scientific Title:Acronym
SUPPORT GN study
Region
| Japan |
Condition
Condition
Renal Diseases
a)IgA nephropathy, purpura nephritis
b)lupus nephritis
c)minimal change nephrotic syndrome, focal segmental glomerulosclerosis
d)ANCA associated vasculitis and related diseases
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate optimal therapy of glomerulonephritis in Japanese patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a. eGFR 30% reduction, end-stage renal disease (initiation of dialysis therapy and renal transplantation) or death
b. complete remission (proteinuria <0.3g/gCr or 0.3g/day)
Key secondary outcomes
a. incomplete remission (proteinuria <1.0g/gCr or 1.0g/day)
b. infectious hospitalization
c. onset of diabetes mellitus
d. cardiovascular event including myocardial infarction, angina pectoris, aortic dissection, aortic rupture and others
e. stroke including cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage and others
f. cancer
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients who have been enrolled in Nagoya-Kidney Disease Registry (N-KDR) and diagnosed renal diseases indicated below by renal biopsy
a)IgA nephropathy, purpura nephritis
b)lupus nephritis
c)minimal change nephrotic syndrome, focal segmental glomerulosclerosis
d)ANCA associated vasculitis and related diseases
Key exclusion criteria
the patients who refuse consent (consent withdrawal)
Target sample size
6500
Research contact person
Name of lead principal investigator
| 1st name | Shoichi |
| Middle name | |
| Last name | Maruyama |
Organization
Nagoya University Graduate School of Medicine, Internal Medicine
Division name
Nephrology
Zip code
464-0056
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
+81-52-744-2192
marus@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Sawako |
| Middle name | |
| Last name | Kato |
Organization
Nagoya University Graduate School of Medicine, Internal Medicine
Division name
Nephrology
Zip code
464-0056
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
+81-52-744-2192
Homepage URL
Kato07@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Nephrology
Institute
Department
Personal name
Funding Source
Organization
CHUGAI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya Universiry Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-741-2111
ethics@med.nagoya-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
| 2018 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient characteristics, Pathological findings by renal biopsy, Clinical findings, Treatment history, Treatment outcome.
Management information
Registered date
| 2018 | Year | 06 | Month | 21 | Day |
Last modified on
| 2021 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037704
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
