UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The novel approach to measure the Kidney Volume in patients with Autosomal Dominant polycystic Kidney Disease
Title of the study (Brief title)	The novel method to measure TKV in patients with ADPKD
Region	Japan

Condition
Condition	Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Classification by specialty	Nephrology Urology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We want to establish the convenient and exact methods to measure the total kidney volume in patients with ADPKD,
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The relationship between accurate kidney volume and ellipsoid kidney volume or VINCENT kidney volume
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) patients with ADPKD 2) patients who is testable plain renal CT
Key exclusion criteria	patients without first-person informed consent
Target sample size	300

Research contact person
Name of lead principal investigator	SATORU MUTO
Organization	Teikyo Universith School of Medicine
Division name	Department of Urology
Address	2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL	0339641211
Email	muto@med.teikyo-u.ac.jp

Public contact
Name of contact person	SATORU MUTO
Organization	Teikyo University School of Medicine
Division name	Urology
Address	2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL	0339641211
Homepage URL
Email	muto@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo University
Institute
Department

Funding Source
Organization	Teikyo University
Organization
Division
Category of Funding Organization	Other
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 10 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 01 Month 01 Day
Anticipated trial start date	2016 Year 01 Month 01 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	no appreciable comment

Management information
Registered date	2016 Year 08 Month 09 Day
Last modified on	2016 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026758