UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study of atypical hemolytic uremic syndrome in Japan
Title of the study (Brief title)	Observational study of atypical hemolytic uremic syndrome in Japan
Region	Japan

Condition
Condition	Atypical hemolytic uremic syndrome (aHUS)
Classification by specialty	Medicine in general Hematology and clinical oncology Nephrology Laboratory medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To survey the epidemiological data of aHUS in Japan.
Basic objectives2	Others
Basic objectives -Others	Prospective and observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To recognize the morbidity, genetic abnormalities, prognosis, and outcomes of treatment in aHUS.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	aHUS patients
Key exclusion criteria	The patients who did not agree to this study.
Target sample size	300

Research contact person
Name of lead principal investigator	Masaomi Nangaku
Organization	The University of Tokyo Hospital School of Medicine
Division name	Division of Nephrology and Endocrinology
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL	03-3815-5411
Email	mnangaku-tky@umin.ac.jp

Public contact
Name of contact person	Yoichiro Ikeda
Organization	The University of Tokyo Hospital School of Medicine
Division name	Division of Nephrology and Endocrinology
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL	03-3815-5411
Homepage URL
Email	ikeda-tky@umin.ac.jp

Sponsor
Institute	Working group of aHUS in Japan
Institute
Department

Funding Source
Organization	National Institute of Public Health
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2014 Year 09 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 04 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	As of 2017, we have registered approximately 140 cases of aHUS.
Other related information	Establishing database system

Management information
Registered date	2014 Year 08 Month 15 Day
Last modified on	2019 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017280