UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031976 |
|---|---|
| Receipt number | 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 16:16:04 |
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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
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
buki.Tatsuki@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co.,Ltd.
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
Bioscientia Institute for Medical Diagnostics GmbH
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036483
