UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027833
Receipt number R000031864
Scientific Title Clinical study using data of kidney transplant patients
Date of disclosure of the study information 2017/06/21
Last modified on 2017/06/20 13:06:58

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Basic information

Public title

Clinical study using data of kidney transplant patients

Acronym

Clinical study using data of kidney transplant patients

Scientific Title

Clinical study using data of kidney transplant patients

Scientific Title:Acronym

Clinical study using data of kidney transplant patients

Region

Japan


Condition

Condition

Kidney transplantation

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To explore factors which contribute to kidney allograft survival

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Kidney allograft survival rate

Key secondary outcomes

The rate of rejection episodes
The occurrence of systemic complications


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

kidney transplant patients

Key exclusion criteria

non kidney transplant patients

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mototsugu Oya

Organization

Keio University school of medicine

Division name

Urology

Zip code


Address

35 Shinanomachi Shinjuku-ku, Tokyo

TEL

03-5363-3825

Email

moto-oya@keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazunobu Shinoda

Organization

Keio University School of Medicine

Division name

Urology

Zip code


Address

35 Shinanomachi Shinjuku-ku, Tokyo

TEL

03-5363-3825

Homepage URL


Email

kshino49@yahoo.co.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

self funding

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

2017 Year 06 Month 21 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

Enrolling by invitation

Date of protocol fixation

2015 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Registration is now ongoing. The analysis will be performed.


Management information

Registered date

2017 Year 06 Month 20 Day

Last modified on

2017 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031864


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name