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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018764
Receipt No. 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

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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
Email 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/
Email kenkyushien@ks.kyorin-u.ac.jp

Sponsor
Institute ADPKD Research section, Kyorin University, School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021708

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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