UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018567 |
|---|---|
| Receipt number | R000021488 |
| Scientific Title | Rituximab administration for chronic antibody-mediated rejection after kidney transplantation |
| Date of disclosure of the study information | 2015/08/14 |
| Last modified on | 2019/02/06 10:00:36 |
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Basic information
Public title
Rituximab administration for chronic antibody-mediated rejection after kidney transplantation
Acronym
Rituximab administration for chronic antibody-mediated rejection after kidney transplantation
Scientific Title
Rituximab administration for chronic antibody-mediated rejection after kidney transplantation
Scientific Title:Acronym
Rituximab administration for chronic antibody-mediated rejection after kidney transplantation
Region
| Japan |
Condition
Condition
Antibody-mediated rejection after kidney transplantation
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the efficiency and safety of rituximab administration for a patient with antibody-mediated rejection after kidney transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in renal function at 6 months
Key secondary outcomes
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
Rituximab administration
Rituximab 375 mg/m2 (maxium dose 500mg)/week x 2 dose
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient who suffer from antibody-mediated rejection after kidney transplantation
Key exclusion criteria
The patient who is judged by the patient's physician as unsuitable for participation in the study
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiko Matsuda |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Nephrology and Hypertension
Zip code
Address
1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL
049-228-3604
akihikom@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiko Matsuda |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Nephrology and Hypertension
Zip code
Address
1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL
049-228-3604
Homepage URL
akihikom@saitama-med.ac.jp
Sponsor or person
Institute
Department of Nephrology and Hypertension, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Nephrology and Hypertension, Saitama Medical Center, Saitama Medical 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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 08 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 06 | Day |
Last modified on
| 2019 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021488
