UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023364 |
|---|---|
| Receipt number | R000026921 |
| Scientific Title | Study of Genetic Test for Renal Pseudohypoaldosteronism Type1 |
| Date of disclosure of the study information | 2016/07/27 |
| Last modified on | 2017/07/28 17:45:51 |
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Basic information
Public title
Study of Genetic Test for Renal Pseudohypoaldosteronism Type1
Acronym
Genetic Test for Renal Pseudohypoaldosteronism Type1
Scientific Title
Study of Genetic Test for Renal Pseudohypoaldosteronism Type1
Scientific Title:Acronym
Genetic Test for Renal Pseudohypoaldosteronism Type1
Region
| Japan |
Condition
Condition
Renal pseudohypoaldosteronism type1
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To make a system for genetic diagnosis of renal pseudohypoaldosteronism type1
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To affirm the strictness of genetic test for renal pseudohypoaldosteronism type1
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
Detect mutations in the gene of renal pseudohypoaldosteronism type1 known as NR3C2 with direct sequence
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
| 0 | years-old | <= |
Age-upper limit
| 8 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who suffers dehydration or hyperkalemia of uncertain cause and are suspected of having renal pseudohypoaldosteronism type1
Key exclusion criteria
In case they have other known disease causing gene mutations
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoaki Mikami |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Department of Nephrology
Zip code
Address
2-8-29, Musashidai, Fuchu-shi, Tokyo
TEL
042-300-5111
naoaki_mikami@tmhp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoaki Mikami |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Department of Nephrology
Zip code
Address
2-8-29, Musashidai, Fuchu-shi, Tokyo
TEL
042-300-5111
Homepage URL
naoaki_mikami@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Children's Medical Center
Organization
Division
Category of Funding Organization
Local Government
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
| 2016 | Year | 07 | Month | 27 | 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
| 2016 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 27 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 27 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 27 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 27 | Day |
Last modified on
| 2017 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026921
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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