UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035338
Receipt number R000040261
Scientific Title The effect of rituximab in desensitization of preoperative DSA positive patients and postoperative ABMR treatment of DSA positive patients in kidney transplantation
Date of disclosure of the study information 2018/12/21
Last modified on 2018/12/21 16:29:10

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Basic information

Public title

The effect of rituximab in desensitization of preoperative DSA positive patients and postoperative ABMR treatment of DSA positive patients in kidney transplantation

Acronym

The effect of rituximab in DSA positive kidney transplant recipients

Scientific Title

The effect of rituximab in desensitization of preoperative DSA positive patients and postoperative ABMR treatment of DSA positive patients in kidney transplantation

Scientific Title:Acronym

The effect of rituximab in DSA positive kidney transplant recipients

Region

Japan


Condition

Condition

Chronic renal failure

Classification by specialty

Nephrology Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the effect of rituximab in desensitization of preoperative DSA positive patients and treatment against ABMR with postoperative DSA positive kidney transplant recipients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Primary endpoint of desensitization:
Attenuation of DSA-MFI(Mean fluorescent intensity) 2 and 4 weeks after rituximab administration.
Primary endpoint of treatment:
Attenuation of DSA-MFI 12 and 24 weeks after rituximab administration

Key secondary outcomes

Secondary endpoint of desensitization:
Lymphocyte crossmatch test 2 weeks after rituximab administration and possibility of kidney transplant.
Secondary endpoint of treatment:
The change of serum Cr.,urinary protein/Cr.ratio, and graft kidney histopathological findings( according to Banff classification)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Preoperaive desensitization for DSA positive patients:After informed consent, patient will be evaluated for adaquacy and recieve the antibody removal by plasmapheresis followed by the first dose of rituximab 375mg/m2 intravenous drip infusion on in house setting. If DSA MFI level decreased lower than 3000 degree, plasmapheresis followed by the second dose rituximab administration will be done 4 weeks after the first dose and kidney transplantation would be performed. If DSA MFI over 3000 degree 2 weeks after the first rituximab administration, plasmapheresis followed by the second dose rituximab would be administrated on 4weeks, and DSA MFI level would be evaluated without kidney transplantation. Administration dose would be adjusted and altered according to bodyweight, age and condition of the patients.
Postoperative treatment for ABMR with DSA production: After informed consent, patient will be evaluated for adaquacy and recieve the antibody removal by plasmapheresis followed by the first dose of rituximab 375mg/m2 intravenous drip infusion on in house setting.If DSA MFI level decreased lower than 3,000 degree, plasmapheresis followed by the second dose rituximab administration will be done 4 weeks after the first dose. Administration dose would be adjusted and altered according to bodyweight, age and condition of the patients.
Clinical course would be carefully followed, then 12 and 24 weeks after treatment, DSA MFI level would be evaluated and kidney graft biopsy would be performed on 24 weeks.

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

Patients whose pre-kidney transplant lymphocyte crossmatch test were positive(DSA positive) and whose crossmatch test turned positive after kidney transplantation with ABMR.
Both gender of patients are acceptable without pregnant and/or possible-pregnant women. Participant age is not limited.
All the participants must received written informed consents.

Key exclusion criteria

Exclusion Criteria:
Patients with cardiac, pulmonary and hepaic dysfunction and severe bone marrow suppression must be excluded.
Hypersensitivity history against rituximab and/or boron, who cannot receive informed consent are also excluded. Patients whomDoctor in charge decided inadequate for participate in this study are excluded.

Criteria in which study must be stopped:
If the participant would expressed refusal against the study.
If the study must be stopped due to the severe adveresed event and/or other reaseons for contraindication for treatment and/or kidney transplantation.
If this study itself must be stopped according to the certain reason.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhide Saito

Organization

Niigata University

Division name

Division of Urology

Zip code


Address

1-757, Asahimachi-dori, chuo-ku, Niigata city, 951-8510, JAPAN

TEL

+81-25-227-2289

Email

kazsaito@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuhide Saito

Organization

Niigata University

Division name

Division of Urology

Zip code


Address

1-757, Asahimachi-dori, chuo-ku, Niigata city, 951-8510, JAPAN

TEL

+81-25-227-2289

Homepage URL


Email

kazsaito@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata University

Institute

Department

Personal name



Funding Source

Organization

Niigata 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

新潟大学医歯学総合病院


Other administrative information

Date of disclosure of the study information

2018 Year 12 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

Open public recruiting

Date of protocol fixation

2013 Year 12 Month 25 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 25 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

2018 Year 12 Month 21 Day

Last modified on

2018 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040261


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name