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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018625
Receipt No. 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

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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
Institute Fujita Health University Hospital
Institute
Department

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
URL(English) https://upload.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


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