UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035027 |
|---|---|
| Receipt number | R000039931 |
| Scientific Title | Association between lifestyles and renal replacement therapy in patients with CKD |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2019/09/06 00:04:06 |
* 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
Association between lifestyles and renal replacement therapy in patients with CKD
Acronym
Lifestyles and renal replacement therapy
Scientific Title
Association between lifestyles and renal replacement therapy in patients with CKD
Scientific Title:Acronym
Lifestyles and renal replacement therapy
Region
| Japan |
Condition
Condition
Chronic Kidney Disease (CKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine associations between lifestyles and initiation of renal replacement therapy in Japanese patients with CKD by using claims database and Specific Health Checkups database from employment-based health insurances.
Basic objectives2
Others
Basic objectives -Others
Relative risks of initiation of renal replacement therapy in group with lifestyle compared to group without.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Initiation of renal replacement therapy (dialysis or kidney transplant).
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
| 40 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1).Insureds and their dependents enrolled in both claims and Specific Health Checkups databases.
2). Those who are at age of 40 to 74 as of March 31 at each fiscal year taken Specific Health Checkups.
3). Those who fulfilled criteria of CKD.
Key exclusion criteria
Those who underwent renal replacement therapy before starting follow-up.
Target sample size
200000
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Urushihara |
Organization
Faculty of Pharmacy, Keio University
Division name
Division of Drug Development and Regulatory Science
Zip code
1058512
Address
1-5-30 Shibakouen, Minato-ku, Tokyo 105-8512, Japan
TEL
03-5400-2649
urushihara.hisashi@keio.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Urushihara |
Organization
Faculty of Pharmacy, Keio University
Division name
Division of Drug Development and Regulatory Science
Zip code
1058512
Address
1-5-30 Shibakouen, Minato-ku, Tokyo 105-8512, Japan
TEL
03-5400-2649
Homepage URL
urushihara.hisashi@keio.jp
Sponsor or person
Institute
Division of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku Medical Megabank Organization, Tohoku University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee for research involving human subjects, Faculty of Pharmacy, Keio University
Address
1-5-30 Shibakouen, Minato-ku, Tokyo 105-8512, Japan
Tel
03-3434-6241
skc-soumu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 01 | 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
149620
Results
Manuscript preparing
Results date posted
| 2019 | Year | 09 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Study design: Retrospective cohort study using claims database and Specific Health Checkups database run by Japan Medical Data Center.
These databases have accumulated claims data since January 2005 and Specific Health Checkups data since April 2008, respectively from several employment-based health insurances. Those who enrolled in these databases are approximately a million as of March 2016.
Management information
Registered date
| 2018 | Year | 11 | Month | 27 | Day |
Last modified on
| 2019 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039931
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
