UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034717 |
|---|---|
| Receipt number | 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 13:12:43 |
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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
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
m-maeda@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
