UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018625
Receipt number R000021552
Scientific Title The intervention trial of the effect of the double induction therapy with basiliximab and rituximab on the production of donor specific antibody after kidney transprantation.
Date of disclosure of the study information 2015/08/10
Last modified on 2015/08/10 14:52:29

* 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

The intervention trial of the effect of the double induction therapy with basiliximab and rituximab on the production of donor specific antibody after kidney transprantation.

Acronym

Double induction therapy with basiliximab and rituximab.

Scientific Title

The intervention trial of the effect of the double induction therapy with basiliximab and rituximab on the production of donor specific antibody after kidney transprantation.

Scientific Title:Acronym

Double induction therapy with basiliximab and rituximab.

Region

Japan


Condition

Condition

Chronic kidney disease

Classification by specialty

Surgery in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effectiveness of the double induction therapy with basiliximab and rituximab on de novo DSA production.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III


Assessment

Primary outcomes

Production of donor specific antibody at two years after kidney transplantation.

Key secondary outcomes

Serum creatinine,eGFR,an incidence of infection,rejection and adverse events at two years after kidney transplantation.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

ABO blood type compatibile transplant

The day of transplantation,administered the rituximab 200mg/body before kidney blood flow resumes.

Other immunosuppressive therapy is,
Basiliximab:20mg/body(0POD and 4POD)
Mycophenolate Mofetil:1500mg/body(from 1POD)
Tacrolimus:0.15mg/kg(-3POD)
Steroids:methylprednisolon 500mg/body(in the pancreas transplantation 250mg/body) on 0POD,in subsequent,take orally Medrol 40mg(in the pancreas transplantation, prednisolone 50mg) and be increased or decreased as appropriate.


ABO blood type incompatible transplant or preexisting DSA

Similarly to the conventional,administered the rituximab 200mg/body two weeks prior to transplantation.

From a week ago before surgery,it enforces plasma exchange, double filtration plasma exchange as appropriate.

Other immunosuppressive therapy is,
Basiliximab:20mg/body(0POD and 4POD)
Mycophenolate Mofetil:1500mg/body(from -14POD)
Tacrolimus:0.15mg/kg(-10POD)
Steroids:methylprednisolon 500mg / body on 0POD,in subsequent,take orally Medrol 40mg and be increased or decreased as appropriate.

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

Renal transplant patient to be enforced in our hospital obtained the consent.

Key exclusion criteria

Patient with a history of hypersensitivity to rituximab.

Patient whom doctor has determined that there is not appropriate participation in this study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Kenmochi

Organization

Fujita Health University Hospital

Division name

Department of Organ Transplant Surgery

Zip code


Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan

TEL

0562-93-9043

Email

kenmochi@fujita-hu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Taihei Ito

Organization

Fujita Health University Hospital

Division name

Department of Organ Transplant Surgery

Zip code


Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan

TEL

0562-93-2380

Homepage URL


Email

i-taihei@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

藤田保健衛生大学病院(愛知県)/Fujita Health University Hospital(Aichi)


Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 10 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

Open public recruiting

Date of protocol fixation

2015 Year 08 Month 05 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 10 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

2015 Year 08 Month 10 Day

Last modified on

2015 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021552


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name