UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037683 |
|---|---|
| Receipt number | R000042975 |
| Scientific Title | Effect of single dose of rituximab on MPO-ANCA related nephritis |
| Date of disclosure of the study information | 2019/08/14 |
| Last modified on | 2019/08/14 14:13:39 |
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Basic information
Public title
Effect of single dose of rituximab on MPO-ANCA related nephritis
Acronym
Effect of single dose of rituximab on MPO-ANCA related nephritis
Scientific Title
Effect of single dose of rituximab on MPO-ANCA related nephritis
Scientific Title:Acronym
Effect of single dose of rituximab on MPO-ANCA related nephritis
Region
| Japan |
Condition
Condition
ANCA related nephritis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the usefulness and safety of a single dose of rituximab to avoid excessive immune suppression.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BVAS before and after treatment (various imaging tests for evaluation, physiological function tests, etc.)
Comparison of histological evaluation in the first and second renal biopsy
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
Single dose of rituximab
375mg/m2 (max 500mg)
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
Cases diagnosed by kidney biopsy as MPO-ANCA related rapidly progressive glomerulonephritis (RPGN)
Key exclusion criteria
1. Serious infections
2. Cases of pulmonary involvement
3. Congestive heart failure
4. Malignant tumor patients
5. History of hypersensitivity to rituximab or mouse-derived protein (mouse type, chimeric type, humanized antibody)
6. Complications that may affect the evaluation of this study
7. Other cases considered inappropriate for participation in this study
8. Pregnant women and cases of possible pregnancy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Arai |
Organization
Toho University
Division name
Dep of Nephro
Zip code
143-8541
Address
6-11-1 Omori-Nishi, Ota-ku
TEL
81337624151
taichi.arai@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Taichi |
| Middle name | |
| Last name | Arai |
Organization
Toho University
Division name
Dep of Nephro
Zip code
143-8541
Address
6-11-1 Omori-Nishi, Ota-ku
TEL
81337624151
Homepage URL
taichi.arai@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University, Faculty of medicine
Address
6-11-1 Omori-Nishi, Ota-ku
Tel
81337624151
taichi.arai@med.toho-u.ac.jp
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
| 2019 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 08 | Month | 14 | Day |
Last modified on
| 2019 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042975
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
