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
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
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
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
