UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Incidence of acute post-streptococcal glomerulonephritis in children
Title of the study (Brief title)	Incidence of APSGN in children
Region	Japan

Condition
Condition	acute post-streptococcal glomerulonephritis
Classification by specialty	Nephrology Infectious disease Pediatrics Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To calculate incidence of acute post-streptococcal glomerulonephritis
Basic objectives2	Others
Basic objectives -Others	To calculate incidence of acute post-streptococcal glomerulonephritis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of acute post-streptococcal glomerulonephritis
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	Not applicable
Age-upper limit	16 years-old >
Gender	Male and Female
Key inclusion criteria	Patient infected with hemolytic streptococcus
Key exclusion criteria	Patient infected hemolytic streptococcus twice within 1 month
Target sample size	1000

Research contact person
Name of lead principal investigator	Shunsuke Shinozuka
Organization	National Hospital Organization Saitama National Hospital
Division name	Department of Pediatrics
Address	2-1, Suwa, Wako City, Saitama, Japan
TEL	048-462-1101
Email	shino@wakho.hosp.go.jp

Public contact
Name of contact person	Shunsuke Shinozuka
Organization	National Hospital Organization Saitama National Hospital
Division name	Department of Pediatrics
Address	2-1, Suwa, Wako City, Saitama, Japan
TEL	048-462-1101
Homepage URL
Email	shino@wakho.hosp.go.jp

Sponsor
Institute	National Hospital Organization Saitama National Hospital
Institute
Department

Funding Source
Organization	National Hospital Organization Saitama National Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 12 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 09 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Cohort study Registration method: All patient who satisfy selection criteria in this hospital or collaborate clinics Examination item: Urinary qualitative analysis

Management information
Registered date	2015 Year 12 Month 07 Day
Last modified on	2018 Year 05 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023230