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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034717
Receipt No. R000039581
Scientific Title Exploratory research using existing sample and information on the effect of M201-A on renal function
Date of disclosure of the study information 2018/10/31
Last modified on 2018/10/31

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Basic information
Public title Exploratory research using existing sample and information on the effect of M201-A on renal function
Acronym M201-A-CR-001
Scientific Title Exploratory research using existing sample and information on the effect of M201-A on renal function
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuji KUMAGAI
Organization Kitasato University Hospital
THE KITASATO INSTITUTE
Division name Clinical Trial Center
Zip code
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
1st name
Middle name
Last name Mika MAEDA
Organization Kitasato University Hospital THE KITASATO INSTITUTE
Division name Department of Pharmacy
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 01 Month 25 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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