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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031976
Receipt No. R000036483
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
Date of disclosure of the study information 2018/03/29
Last modified on 2019/09/25

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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
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
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
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 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

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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