UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006613
Receipt number R000007821
Scientific Title Clinical study on the administration before ABO incompatible kidney transplantation
Date of disclosure of the study information 2011/11/01
Last modified on 2015/05/01 12:12:23

* 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

Clinical study on the administration before ABO incompatible kidney transplantation

Acronym

Clinical study on the administration before ABO incompatible kidney transplantation

Scientific Title

Clinical study on the administration before ABO incompatible kidney transplantation

Scientific Title:Acronym

Clinical study on the administration before ABO incompatible kidney transplantation

Region

Japan


Condition

Condition

ABO incompatible kidney transplantation

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to assess the efficacy and safety of rutuximab for the recipients of ABO incompatible kidney transplantation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

graft survival

Key secondary outcomes

presence of the immunological rejection onset


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

administration of retuximab

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

5 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

the patients who will be given ABO incompatible renal transprantation

Key exclusion criteria

the patients who dose not hope for transplantation previous treatment by adminstration of rituximab

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kunihisa Yamaguchi

Organization

University of Tokushima

Division name

Urology

Zip code


Address

3-18-15 Kuramoto, tokushima, 7708503 Japan

TEL

088-633-7159

Email

yamaguchi.kunihisa@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kunihisa Yamaguchi

Organization

University of Tokushima

Division name

Urology

Zip code


Address

3-18-15 Kuramoto, tokushima, 7708503 Japan

TEL

088-633-7159

Homepage URL


Email

kunihisa-y@clin.med.tokushima-u.ac.jp


Sponsor or person

Institute

Departoment of Urology, Tokushima University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Departoment of Urology, Tokushima University Graduate School of Medicine

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

2011 Year 11 Month 01 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

2011 Year 10 Month 30 Day

Date of IRB


Anticipated trial start date

2011 Year 11 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



Management information

Registered date

2011 Year 10 Month 25 Day

Last modified on

2015 Year 05 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007821


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name