UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003843
Receipt number R000004629
Scientific Title Birth weight of dialysis patients and dialysis initiation
Date of disclosure of the study information 2010/06/29
Last modified on 2014/07/08 17:36:19

* 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

Birth weight of dialysis patients and dialysis initiation

Acronym

Birth weight of dialysis patients and dialysis initiation

Scientific Title

Birth weight of dialysis patients and dialysis initiation

Scientific Title:Acronym

Birth weight of dialysis patients and dialysis initiation

Region

Japan


Condition

Condition

dialysis patients

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the relation between birth weight and initiation of dialysis

Basic objectives2

Others

Basic objectives -Others

epidemiology

Trial characteristics_1


Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Age on initiation of dialysis

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

chronic dialysis patients

Key exclusion criteria

patients without consent

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kunihiro Yamagata

Organization

Graduate School of Comprehensive Human Sciences, University of Tsukuba

Division name

Pathophysiology of Renal Disease

Zip code


Address

1-1-1 Tennodai, Tsukuba, Ibaraki

TEL

029-853-3202

Email

k-yamaga@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Chie Saito

Organization

Graduate School of Comprehensive Human Sciences, University of Tsukuba

Division name

Pathophysiology of Renal Disease

Zip code


Address

1-1-1 Tennodai, Tsukuba, Ibaraki

TEL

029-853-3202

Homepage URL


Email

chie.saito@md.tsukuba.ac.jp


Sponsor or person

Institute

Pathophysiology of Renal Disease, Graduate School of Comprehensive Human Sciences, University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

Pathophysiology of Renal Disease, Graduate School of Comprehensive Human Sciences, University of Tsukuba

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


Address


Tel


Email



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

2010 Year 06 Month 29 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://onlinelibrary.wiley.com/doi/10.1111/1744-9987.12159/full

Number of participants that the trial has enrolled


Results

Lower-than-mean birth weight would be a risk for ESRD in patients with DM in later life.

Results date posted


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

2009 Year 04 Month 16 Day

Date of IRB


Anticipated trial start date

2010 Year 07 Month 01 Day

Last follow-up date

2011 Year 12 Month 01 Day

Date of closure to data entry

2011 Year 12 Month 01 Day

Date trial data considered complete

2012 Year 12 Month 01 Day

Date analysis concluded

2013 Year 12 Month 01 Day


Other

Other related information

cross-sectional study


Management information

Registered date

2010 Year 06 Month 29 Day

Last modified on

2014 Year 07 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004629


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name