UMIN-ICDR Clinical Trial

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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018641
Receipt No. R000021578
Scientific Title Japanese Society for Dialysis Therapy Renal Data Registry
Date of disclosure of the study information 2015/08/12
Last modified on 2019/08/19

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Basic information
Public title Japanese Society for Dialysis Therapy Renal Data Registry
Acronym JRDR
Scientific Title Japanese Society for Dialysis Therapy Renal Data Registry
Scientific Title:Acronym JRDR
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To clarify the current status and problems of renal replacement therapy (RRT) in Japan
2. To standardize prescriptions of the patients on RRT
3. To ameliorate the quality of life and prognosis of the patients on RRT
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Dead or Alive
Key secondary outcomes Cerebral infarction, Cerebral hemorrhage, Myocardial infarction, Amputation on limbs, and other outcomes as necessary

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All patients on chronic RRT as of Dec. 31 in each surveillance year in Japan
Key exclusion criteria Patients with acute kidney injury on RRT
Target sample size 335000

Research contact person
Name of lead principal investigator
1st name Hidetomo
Middle name
Last name Nakamoto
Organization Japanese Society for Dialysis Therapy
Division name Administrative board
Zip code 113-0033
Address 2-38-21 Hongo, Bunkyo-ku, Tokyo
TEL +81-3-58000786
Email office@jsdt.or.jp

Public contact
Name of contact person
1st name Kosaku
Middle name
Last name Nitta
Organization Japanese Society for Dialysis Therapy
Division name Committee of Renal Data Registry
Zip code 113-0033
Address 2-38-21 Hongo, Bunkyo-ku, Tokyo
TEL +81-3-58000786
Homepage URL http://www.jsdt.or.jp/info/1789.html
Email toukei@jsdt.or.jp

Sponsor
Institute Japanese Society for Dialysis Therapy
Institute
Department

Funding Source
Organization Japanese Society for Dialysis Therapy
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 Ethics Committee, Japanese Society for Dialysis Therapy
Address 2-38-21 Hongo, Bunkyo-ku, Tokyo
Tel +81-3-58000786
Email office@jsdt.or.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
2015 Year 08 Month 12 Day

Related information
URL releasing protocol http://www.jsdt.or.jp/info/1789.html
Publication of results Unpublished

Result
URL related to results and publications https://docs.jsdt.or.jp/overview/index.html
Number of participants that the trial has enrolled 334505
Results
We are preparing the 2018 survey.

We have been analyzing 2017 data. 

2016 annual dialysis data report has been opened and available on our Web site. 



Results date posted
2019 Year 08 Month 19 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 12 Month 01 Day
Date of IRB
2017 Year 08 Month 21 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
2019 Year 07 Month 31 Day
Date trial data considered complete
2019 Year 09 Month 30 Day
Date analysis concluded
2019 Year 12 Month 26 Day

Other
Other related information The current study is performed annually to collect data about therapeutic prescriptions of dialysis and outcome parameters such as dead/alive and other major complications. Using these parameters we mainly analyze what kind of practice patterns are favorable to get good results.
If you are a dialysis patient and want to know whether you had been registered to the registry, you can see it in the dialysis facility where you were treated at the end of the previous year.

Management information
Registered date
2015 Year 08 Month 11 Day
Last modified on
2019 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021578

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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