UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019614 |
|---|---|
| Receipt number | R000022372 |
| Scientific Title | Research on the pathogenesis of autosomal dominant polycystic kidney disease |
| Date of disclosure of the study information | 2015/11/02 |
| Last modified on | 2021/05/07 11:12:42 |
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Basic information
Public title
Research on the pathogenesis of autosomal dominant polycystic kidney disease
Acronym
ADPKD-Hokkaido-1
Scientific Title
Research on the pathogenesis of autosomal dominant polycystic kidney disease
Scientific Title:Acronym
ADPKD-Hokkaido-1
Region
| Japan |
Condition
Condition
Autosomal dominant polycystic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To explore prognostic factors in Japanese patients with ADPKD based on information in electronic medical charts and genetic information collected from patients with ADPKD who have visited or been admitted to Hokkaido University Hospital or its related hospitals
Basic objectives2
Others
Basic objectives -Others
Risk factors for increase in kidney volume, which is considered a surrogate marker of reduction in renal function, as well as complications such as cerebral aneurysm, will be explored
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of factors that may affect the progression of ADPKD (annual percentage change in kidney volume)
Key secondary outcomes
Evaluation of factors that may affect the progression of ADPKD (annual change in eGFR)
Exploration of factors that may affect the onset of ADPKD-related events (cerebral aneurysm, hypertension, urolithiasis, renal pain, macroscopic hematuria, cyst infection, urinary tract infection, proteinuria, dialysis, and other ADPKD-related events) and other major events (e.g., cardiovascular events)
Comparison of genetic background information between subjects and healthy adults
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
Patients with a diagnosis of ADPKD who have visited or been admitted to Hokkaido University Hospital or its related hospitals at least twice
Patients who meet the following criterion if blood and/or urine samples will be collected:
- Patients who are capable to consent
Key exclusion criteria
Patients who meet the following criterion if blood and/or urine samples will be collected:
- Patients who, in the opinion of the investigator, are inappropriate for the study
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Saori |
| Middle name | |
| Last name | Nishio |
Organization
Hokkaido University School of Medicine
Division name
Department of Medicine II
Zip code
060-8648
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Japan
TEL
011-706-5915
saorin@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Nishio |
Organization
Hokkaido University School of Medicine
Division name
Department of Medicine II
Zip code
060-8648
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Japan
TEL
011-706-5915
Homepage URL
saorin@med.hokudai.ac.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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
Tel
+81-11-706-5915
saorin@med.hokudai.ac.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
北海道大学病院（北海道）、北見赤十字病院（北海道）、旭川医科大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 02 | 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
255
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
We need time to analyze the data.
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of factors that may affect the progression of ADPKD (annual change in eGFR)
Exploration of factors that may affect the onset of ADPKD-related events (cerebral aneurysm, hypertension, urolithiasis, renal pain, macroscopic hematuria, cyst infection, urinary tract infection, proteinuria, dialysis, and other ADPKD-related events) and other major events (e.g., cardiovascular events)
Comparison of genetic background information between subjects and healthy adults
Management information
Registered date
| 2015 | Year | 11 | Month | 02 | Day |
Last modified on
| 2021 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022372
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
