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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033077
Receipt No. 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 2019/07/17

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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
Email 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
Email Kato07@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine, Nephrology
Institute
Department

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
Email 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 Enrolling by invitation
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
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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