UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018764 |
|---|---|
| Receipt number | R000021708 |
| Scientific Title | Clinical implications of DNA analysis on ADPKD |
| Date of disclosure of the study information | 2015/08/22 |
| Last modified on | 2019/02/26 10:17:02 |
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Basic information
Public title
Clinical implications of DNA analysis on ADPKD
Acronym
DNAPKD study
Scientific Title
Clinical implications of DNA analysis on ADPKD
Scientific Title:Acronym
DNAPKD study
Region
| Japan |
Condition
Condition
Autosomal Dominant Polycystic Kidney Disease
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Mutation types of PKD1 and PKD2 are re-classified according to the effect on polycystin 1 and 2 structures. Then the relationships between new classification and clinical indices are examined.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between mutational type and phenotype.
Key secondary outcomes
The efficacy of next generation sequencing method
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
Autosomal Dominant Polycystic Kidney Disease
Key exclusion criteria
The patients who do not consent.
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Higashihara |
Organization
Kyorin University School of Medicine
Division name
ADPKD Research
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-49-7428
ehigashi@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumie Kobayashi |
Organization
Research Promoting Center
Division name
Kyorin University Research Promoting Center
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
Homepage URL
http://www.kyorin-u.ac.jp/univ/society/study/
kenkyushien@ks.kyorin-u.ac.jp
Sponsor or person
Institute
ADPKD Research section, Kyorin University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Otsuka Pharmaceutical Co., Ltd.
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
| 2015 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
1)Kinoshita M, Higashihara E, Kawano H, Higashiyama R, Koga D, Fukui T, Gondo N, Oka T, Kawahara K, Rigo K, Hague T, Katsuragi K, Sudo K, Takeshi M, Horie S, Nutahara K. Technical evaluation: Identification of pathogenic mutations in PKD1 and PKD2 in patients with autosomal dominant polycystic kidney disease by next-generation sequencing and use of a comprehensive new classification system. PLoS One. 11: e0166288. 2016.
2)Higashihara E, Horie S, Kinoshita M, Harris P, Okegawa T, Tanbo M, Hara H, Yamaguchi T, Shigemori K, Kawano H, Miyazaki I, Kaname S, Nutahara K. A potentially crucial role of the PKD1 C terminal tail in renal prognosis. Clin Exp Nephrol. 22: 395-404. 2017.
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
| 2013 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 30 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2015 | Year | 08 | Month | 22 | Day |
Last modified on
| 2019 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021708
