UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047533 |
|---|---|
| Receipt number | R000052872 |
| Scientific Title | Exploratory data base study: TEMPO post-hoc AI based image analysis study |
| Date of disclosure of the study information | 2022/04/21 |
| Last modified on | 2023/05/12 13:54:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Exploratory data base study: TEMPO post-hoc AI based image analysis study
Acronym
TEMPO image AI study
Scientific Title
Exploratory data base study: TEMPO post-hoc AI based image analysis study
Scientific Title:Acronym
TEMPO image AI study
Region
| Japan | North America | South America |
| Australia | Europe |
Condition
Condition
Autosomal Dominant Polycystic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With the AI analysis, we intend to create a prediction formula from the baseline values and the kidney images for the ADPKD disease progression and the tolvaptan effect to the kidney.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tolvaptan's renal protective effect (Categorized evaluation of kidney function through the change)
Kidney function progression in placebo group (categorized evaluation of worsening renal function in the placebo group)
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient who are participated in tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD) (TEMPO3:4)
Key exclusion criteria
Same as Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD) (TEMPO3:4)
Target sample size
1444
Research contact person
Name of lead principal investigator
| 1st name | Lyo |
| Middle name | |
| Last name | Inuyama |
Organization
Otsuka Pharmaceutical Ltd.
Division name
Medical Affairs
Zip code
108-8242
Address
2-16-4 Konan, Minato-ku, Tokyo
TEL
03-6717-1400
Inuyama.Lyo@otsuka.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Tanaka |
Organization
Otsuka Pharmaceutical Ltd.
Division name
Medical Affairs
Zip code
108-8242
Address
2-16-4 Konan, Minato-ku, Tokyo
TEL
03-6717-1400
Homepage URL
Tanaka.toshiki@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Medical Affairs Department
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Medical Affairs Department
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The research ethics committee of Otsuka Pharmaceutical Co., Ltd
Address
463-10 Kagasuno,Kawauchi-cho,Tokushima-city,Tokushima
Tel
088-665-2126
Imaizumi.Takashi@otsuka.jp
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
| 2022 | Year | 04 | Month | 21 | 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
1444
Results
Using TEMPO3:4 data, we extracted features in kidney images and constructed a model to predict disease progression using kidney image features and clinical data. A model of disease progression in patients receiving tolvaptan was also constructed.
Results date posted
| 2023 | Year | 05 | Month | 08 | Day |
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
| 2021 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 08 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis of below contents
-Tolvaptan's renal protective effect(Categorized evaluation of kidney function through the change)
-Kidney function progression in placebo group (categorized evaluation of worsening renal function in the placebo group)
Management information
Registered date
| 2022 | Year | 04 | Month | 20 | Day |
Last modified on
| 2023 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052872
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
