UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000018641
Receipt number R000021578
Scientific Title Japanese Society for Dialysis Therapy Renal Data Registry
Date of disclosure of the study information 2015/08/12
Last modified on 2021/10/08 10:40:42

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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

340000


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 or person

Institute

Japanese Society for Dialysis Therapy

Institute

Department

Personal name



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

Main results already published

Date of protocol fixation

2018 Year 12 Month 01 Day

Date of IRB

2019 Year 10 Month 25 Day

Anticipated trial start date

2020 Year 01 Month 01 Day

Last follow-up date

2020 Year 06 Month 30 Day

Date of closure to data entry

2020 Year 07 Month 31 Day

Date trial data considered complete

2020 Year 09 Month 30 Day

Date analysis concluded

2020 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

2021 Year 10 Month 08 Day



Link to view the page

Value
https://center6.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