UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical implications of DNA analysis on ADPKD
Title of the study (Brief title)	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	Eiji Higashihara
Organization	Kyorin University School of Medicine
Division name	ADPKD Research
Address	6-20-2 Shinkawa, Mitaka, Tokyo
TEL	0422-49-7428
Email	ehigashi@ks.kyorin-u.ac.jp

Public contact
Name of contact person	Fumie Kobayashi
Organization	Research Promoting Center
Division name	Kyorin University Research Promoting Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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/icdr_e/ctr_view.cgi?recptno=R000021708