UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036087
Receipt number R000012565
Scientific Title Retrospective analysis of factors influencing long term outcome of kidney transplantation
Date of disclosure of the study information 2019/03/31
Last modified on 2019/03/05 13:32:44

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Basic information

Public title

Retrospective analysis of factors influencing long term outcome of kidney transplantation

Acronym

Retrospective analysis of factors influencing long term outcome of kidney transplantation

Scientific Title

Retrospective analysis of factors influencing long term outcome of kidney transplantation

Scientific Title:Acronym

Retrospective analysis of factors influencing long term outcome of kidney transplantation

Region

Japan


Condition

Condition

Chronic renal failure

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the factors which influence the longterm outcome of kidney transplantation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

patient survival and kidney graft survival

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

kidney transplant patients who were performed one-year protocol kidney graft biopsy

Key exclusion criteria

none

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shiro Takahara

Organization

Osaka University

Division name

Advanced Technology for Transplantation

Zip code


Address

2-2, J8, Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3746

Email

takahara@att.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naotsugu Ichimaru

Organization

Osaka University

Division name

Advanced Technology for Transplantation

Zip code


Address

2-2, J8, Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3746

Homepage URL


Email

ichimaru@att.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Advanced Technology for Transplantation, Osaka University

Institute

Department

Personal name



Funding Source

Organization

Astellas Pharma Inc.

Organization

Division

Category of Funding Organization

Profit organization

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

2019 Year 03 Month 31 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


Results


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

Completed

Date of protocol fixation

2013 Year 05 Month 15 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Ten-year kidney graft survival was significantly deteriorated in de novo DSA-positive at the first year after kidney transplantation cases.


Management information

Registered date

2019 Year 03 Month 05 Day

Last modified on

2019 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012565


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name