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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035338
Receipt No. 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

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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
Institute Niigata University
Institute
Department

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
URL(English) https://upload.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


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