UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023552 |
|---|---|
| Receipt number | R000026758 |
| Scientific Title | The novel approach to measure the Kidney Volume in patients with Autosomal Dominant polycystic Kidney Disease |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2016/08/09 08:21:04 |
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Basic information
Public title
The novel approach to measure the Kidney Volume in patients with Autosomal Dominant polycystic Kidney Disease
Acronym
The novel method to measure TKV in patients with ADPKD
Scientific Title
The novel approach to measure the Kidney Volume in patients with Autosomal Dominant polycystic Kidney Disease
Scientific Title:Acronym
The novel method to measure TKV in patients with ADPKD
Region
| Japan |
Condition
Condition
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Classification by specialty
| Nephrology | Urology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We want to establish the convenient and exact methods to measure the total kidney volume in patients with ADPKD,
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between accurate kidney volume and ellipsoid kidney volume or VINCENT kidney volume
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients with ADPKD
2) patients who is testable plain renal CT
Key exclusion criteria
patients without first-person informed consent
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | SATORU MUTO |
Organization
Teikyo Universith School of Medicine
Division name
Department of Urology
Zip code
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL
0339641211
muto@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | SATORU MUTO |
Organization
Teikyo University School of Medicine
Division name
Urology
Zip code
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL
0339641211
Homepage URL
muto@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Teikyo University
Organization
Division
Category of Funding Organization
Other
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 | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no appreciable comment
Management information
Registered date
| 2016 | Year | 08 | Month | 09 | Day |
Last modified on
| 2016 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026758
