UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018567
Receipt number R000021488
Scientific Title Rituximab administration for chronic antibody-mediated rejection after kidney transplantation
Date of disclosure of the study information 2015/08/14
Last modified on 2019/02/06 10:00:36

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Basic information

Public title

Rituximab administration for chronic antibody-mediated rejection after kidney transplantation

Acronym

Rituximab administration for chronic antibody-mediated rejection after kidney transplantation

Scientific Title

Rituximab administration for chronic antibody-mediated rejection after kidney transplantation

Scientific Title:Acronym

Rituximab administration for chronic antibody-mediated rejection after kidney transplantation

Region

Japan


Condition

Condition

Antibody-mediated rejection after kidney transplantation

Classification by specialty

Nephrology Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study investigates the efficiency and safety of rituximab administration for a patient with antibody-mediated rejection after kidney transplantation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in renal function at 6 months

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Rituximab administration
Rituximab 375 mg/m2 (maxium dose 500mg)/week x 2 dose

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

18 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

The patient who suffer from antibody-mediated rejection after kidney transplantation

Key exclusion criteria

The patient who is judged by the patient's physician as unsuitable for participation in the study

Target sample size

1


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihiko Matsuda

Organization

Saitama Medical Center, Saitama Medical University

Division name

Department of Nephrology and Hypertension

Zip code


Address

1981 Kamoda, Kawagoe, Saitama 350-8550, Japan

TEL

049-228-3604

Email

akihikom@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akihiko Matsuda

Organization

Saitama Medical Center, Saitama Medical University

Division name

Department of Nephrology and Hypertension

Zip code


Address

1981 Kamoda, Kawagoe, Saitama 350-8550, Japan

TEL

049-228-3604

Homepage URL


Email

akihikom@saitama-med.ac.jp


Sponsor or person

Institute

Department of Nephrology and Hypertension, Saitama Medical Center, Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Department of Nephrology and Hypertension, Saitama Medical Center, Saitama Medical University

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

2015 Year 08 Month 14 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

Preinitiation

Date of protocol fixation

2015 Year 08 Month 14 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 14 Day

Last follow-up date

2018 Year 09 Month 30 Day

Date of closure to data entry

2018 Year 09 Month 30 Day

Date trial data considered complete

2018 Year 09 Month 30 Day

Date analysis concluded

2018 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2015 Year 08 Month 06 Day

Last modified on

2019 Year 02 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021488


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name