UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory research using existing sample and information on the effect of M201-A on renal function
Title of the study (Brief title)	M201-A-CR-001
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect on kidney function when M201-A hydrochloride injection was administered intravenously
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood Na, K, Cl, Creatinine Urine Na, K, Cl, Creatinine
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	40 years-old >
Gender	Male
Key inclusion criteria	-Japanese Healthy Male subjects -Age 20 to less than 40 years of age -Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2 -Written informed consent must be obtained on a voluntary basis before any assessment is performed.
Key exclusion criteria	-Presence or past medical history of hepatic impairments, renal impairments, cardiovascular disease, gastrointestinal disease and others which are inappropriate for participating in this clinical trial -Past medical history of cancer, cerebral infarction or cardiac infarction -Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials -QTcF > 450ms at the screening examination -NT-proBNP > 125 pg/mL at the screening examination -Any risk factors of Torsades de Pointes including such as heart failure, hypokalemia, long QT interval syndrome due to family medical history
Target sample size	39

Research contact person
Name of lead principal investigator	Yuji KUMAGAI
Organization	Kitasato University Hospital THE KITASATO INSTITUTE
Division name	Clinical Trial Center
Address	1-15-1 Kitasato, Minami-ku, Sagamihara Kanagawa 252-0375, Japan
TEL	042-778-9965
Email	kuma-guy@za2.so-net.ne.jp

Public contact
Name of contact person	Mika MAEDA
Organization	Kitasato University Hospital THE KITASATO INSTITUTE
Division name	Department of Pharmacy
Address	1-15-1 Kitasato, Minami-ku, Sagamihara Kanagawa 252-0375, Japan
TEL	042-778-9775
Homepage URL	http://www.khp.kitasato-u.ac.jp/bumon/chiken/index.html
Email	m-maeda@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
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	2018 Year 10 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 25 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2018 Year 03 Month 12 Day
Date analysis concluded	2018 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	In this study, electrolytes were measured using blood and urine specimens already obtained in Clinical trial M201-A-CT-001, and the effect of M201-A on renal function was examined.

Management information
Registered date	2018 Year 10 Month 31 Day
Last modified on	2018 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039581