UMIN-CTR Clinical Trial

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

Chronic renal failure

Classification by specialty

Nephrology

Urology

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Niigata University

Institute

Department

Personal name

Organization

Niigata University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

新潟大学医歯学総合病院

Date of disclosure of the study information

2018

Year

12

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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