UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019600 |
|---|---|
| Receipt number | R000022658 |
| Scientific Title | Pregnancy and Progression of Autosomal Dominant Polycystic Kidney Disease |
| Date of disclosure of the study information | 2015/11/02 |
| Last modified on | 2019/11/05 16:00:00 |
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Basic information
Public title
Pregnancy and Progression of Autosomal Dominant Polycystic Kidney Disease
Acronym
Pregnancy and Progression of Autosomal Dominant Polycystic Kidney Disease
Scientific Title
Pregnancy and Progression of Autosomal Dominant Polycystic Kidney Disease
Scientific Title:Acronym
Pregnancy and Progression of Autosomal Dominant Polycystic Kidney Disease
Region
| Japan |
Condition
Condition
Women with Autosomal Dominant Polycystic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To asess the characteristic of pregnancy course and progression of renal failure in Autosomal Dominant Polycystic Kidney Disease.
Basic objectives2
Others
Basic objectives -Others
To asess the characteristic of pregnancy course and progression of renal failure in Autosomal Dominant Polycystic Kidney Disease.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
End Stage Renal Disease
Key secondary outcomes
Pregnancy outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
questionnaire
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
| Not applicable |
Gender
Female
Key inclusion criteria
Women with Autosomal Dominant Polycystic Kidney Disease
Key exclusion criteria
Under 20 years old
No agreement
No child
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Ubara |
Organization
Toranomon Hospital
Division name
Kidney Center
Zip code
2138587
Address
1-3-1 Kajigaya Takatsuku Kawasaki Kanagawa
TEL
044-877-5111
Ubara@toranomon.gr
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Hayami |
Organization
Toranomon Hospital
Division name
Kidney Center
Zip code
2138587
Address
1-3-1 Kajigaya Takatsuku Kawasaki Kanagawa
TEL
044-877-5111
Homepage URL
non_love_99@yahoo.co.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toranomon Hospital
Address
1-3-1 kajigaya takatsu-ku Kawasaki-shi Kanagawa
Tel
044-877-5111
non_love_99@yahoo.co.jp
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
| 2015 | Year | 11 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 02 | Day |
Last modified on
| 2019 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022658
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
