UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037704