UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032113 |
|---|---|
| Receipt number | R000036634 |
| Scientific Title | Desensitization with rituximab for preformed anti-donor antibody and antibody-mediated rejection in kidney transplantation. |
| Date of disclosure of the study information | 2018/04/05 |
| Last modified on | 2020/10/06 17:50:59 |
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Basic information
Public title
Desensitization with rituximab for preformed anti-donor antibody and antibody-mediated rejection in kidney transplantation.
Acronym
Desensitization with rituximab for preformed anti-donor antibody and antibody-mediated rejection in kidney transplantation.
Scientific Title
Desensitization with rituximab for preformed anti-donor antibody and antibody-mediated rejection in kidney transplantation.
Scientific Title:Acronym
Desensitization with rituximab for preformed anti-donor antibody and antibody-mediated rejection in kidney transplantation.
Region
| Japan |
Condition
Condition
end stage renal disease
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of pre transplant desensitization with rituximab for preformed anti-donor antibody in kidney transplant recipients and treatment for antibody-mediated rejection with rituximab in kidney transplant recipients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
value of anti-donor antibody
Key secondary outcomes
kidney graft function
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
200mg of rituximab will given twice intravenously for each patient. Rituximab will reduce to 100mg for pediatric patients.
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
| 10 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with preformed anti-donor antibody and/or antibody-mediated rejection
Key exclusion criteria
active infection
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Yamamoto |
Organization
Hyogo College of Medicine
Division name
Kidney Transplant Center and Department of Urology
Zip code
6638501
Address
1-1 Mukogawacho, Nishinomiya, Hyogo Japan
TEL
0798-45-6366
nojimam@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Nojima |
Organization
Hyogo College of Medicine
Division name
Department of Urology
Zip code
6638501
Address
1-1 Mukogawacho, Nishinomiya, Hyogo Japan
TEL
0798-45-6366
Homepage URL
nojimam@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo College of Medicine
Address
1-1 Mukogawacho, Noshinomiya Hyogo, Japan
Tel
N/A
N/A
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2008 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2008 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2008 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 05 | Day |
Last modified on
| 2020 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036634
