UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory Study of Genetic Factors Related to the Inhibitory Effect of Tolvaptan on Increased Kidney Volume in Patients with Autosomal Dominant Polycystic Kidney Disease
Acronym	To explore genome biomarkers for Tolvaptan efficacy in ADPKD
Scientific Title	Exploratory Study of Genetic Factors Related to the Inhibitory Effect of Tolvaptan on Increased Kidney Volume in Patients with Autosomal Dominant Polycystic Kidney Disease
Scientific Title:Acronym	To explore genome biomarkers for Tolvaptan efficacy in ADPKD
Region	Japan North America Europe

Condition
Condition	Autosomal Dominant Polycystic Kidney Disease
Classification by specialty	Nephrology Urology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To explore genetic factors related to the inhibitory effect of Tolvaptan on increased kidney volume, and possible other efficacy parameters, in patients with ADPKD
Basic objectives2	Others
Basic objectives -Others	To explore genetic factors related to Tolvaptan efficacy
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Genetic factors related to the inhibitory effect of Tolvaptan on increased kidney volume
Key secondary outcomes	Genetic factors related to the other possible parameters of Tolvaptan efficacy.

Base
Study type	Others,meta-analysis etc

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
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Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	55 years-old >=
Gender	Male and Female
Key inclusion criteria	The clinical data and genomic variants of Patients who have completed TEMPO(Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes)3-4 Trial (Refer to ClinicalTrials.gov: NCT00428948)
Key exclusion criteria	Patients who did not participate in extension Trial(Refer to ClinicalTrials.gov:NCT01280721 or NCT01214421)
Target sample size	890

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tatsuki Ibuki
Organization	Otsuka Pharmaceutical Co.,Ltd.
Division name	Medical Affairs
Zip code
Address	Kagasuno463-10,kawauchi-cho,Tokushima-shi,Tokushima 771-0192 Japan
TEL	+81-88-665-2126
Email	Ibuki.Tatsuki@otsuka.jp

Public contact
Name of contact person	1st name Middle name Last name Tatsuki Ibuki
Organization	Otsuka Pharmaceutical Co.,Ltd.
Division name	Medical Affairs
Zip code
Address	Kagasuno 463-10, kawauchi-cho, Tokushima-shi, Tokushima 771-0192 Japan
TEL	+81-88-665-2126
Homepage URL
Email	buki.Tatsuki@otsuka.jp

Sponsor
Institute	Otsuka Pharmaceutical Co.,Ltd.
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	Bioscientia Institute for Medical Diagnostics GmbH
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	2018 Year 03 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Results Delayed
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 27 Day
Date of IRB	2018 Year 01 Month 30 Day
Anticipated trial start date	2018 Year 03 Month 30 Day
Last follow-up date	2019 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To explore genetic factors related to Tolvaptan efficacy based on the association between clinical data from TEMPO34 (ClinicalTrials.gov: NCT00428948) and genomic data using with DNA samples collected in 2 extension trials (ClinicalTrials.gov: NCT01280721, NCT01214421).

Management information
Registered date	2018 Year 03 Month 29 Day
Last modified on	2019 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036483