UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of relationship between congenital anomalies of kidney and urinary tract and renin-angiotensin system
Title of the study (Brief title)	Examination of relationship between CAKUT and RAS
Region	Japan

Condition
Condition	Congenital Anomalies of Kidney and Urinary Tract
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investidate relationship between congenital anomalies of kidney and urinary tract and renin angiotensin system
Basic objectives2	Others
Basic objectives -Others	To investidate relationship between congenital anomalies of kidney and urinary tract and the value of renin angiotensin system in serum and urine
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Significant relationship between congenital anomalies of kidney and urinary tract and renin angiotensin system
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	0 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	Congenital anomalies of kidney and urinary tract
Key exclusion criteria	do not have congenital anomalies of kidney and urinary tract
Target sample size	50

Research contact person
Name of lead principal investigator	Shingo Ishimori
Organization	Takatsuki General hospital
Division name	Department of pediatrics
Address	1-3-13 Kosobecho, Takatsuki city, Osaka
TEL	0726813801
Email	shingo-i0324os@live.jp

Public contact
Name of contact person	Shingo Ishimori
Organization	Takatsuki General hospital
Division name	Department of pediatrics
Address	1-3-13 Kosobecho, Takatsuki city, Osaka
TEL	0726813801
Homepage URL
Email	shingo-i0324os@live.jp

Sponsor
Institute	Takatsuki General hospital
Institute
Department

Funding Source
Organization	Takatsuki General 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	2016 Year 12 Month 17 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 12 Month 17 Day
Anticipated trial start date	2016 Year 12 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The value of various examination in abdominal ultrasound,serum and urine

Management information
Registered date	2016 Year 12 Month 17 Day
Last modified on	2018 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029115