UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005231 |
|---|---|
| Receipt number | R000006223 |
| Scientific Title | Uncontrol trial of rituximab treatment on steroid dependent and frequently relapsing minimal cahnge nephrotic syndrome(MCNS) |
| Date of disclosure of the study information | 2011/03/10 |
| Last modified on | 2016/04/30 23:33:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Uncontrol trial of rituximab treatment on steroid dependent and frequently relapsing minimal cahnge nephrotic syndrome(MCNS)
Acronym
Uncontrol trial of rituximab treatment on steroid dependent and frequently relapsing minimal cahnge nephrotic syndrome(MCNS)
Scientific Title
Uncontrol trial of rituximab treatment on steroid dependent and frequently relapsing minimal cahnge nephrotic syndrome(MCNS)
Scientific Title:Acronym
Uncontrol trial of rituximab treatment on steroid dependent and frequently relapsing minimal cahnge nephrotic syndrome(MCNS)
Region
| Japan |
Condition
Condition
steroid dependent and frequently relapsing minimal change nephrotic syndrome
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects and safety of rituximab in adult patients with steroid dependent and frequently relapsing MCNS
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
relapse
the cumlative dose of prednisolone
the cumulative dose of cyclosporin
Key secondary outcomes
the adverse effect of prednisolone
the adverse effect of cyclosporin
the adverse effect of rituximab
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 375mg/m2 single-dose
1 time/6months
24 months follow up
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
steroid dependent and frequently relapsing nephrotic syndrome patients,
minimal change disease on biopsy,
patients gave written informed consent for participation in the study
Key exclusion criteria
positive serology for hepatitis B and C, HIV and antinuclear antibodies,
sereve renal dysfunction and liver dysfunction, pregnant woman
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kosaku Nitta |
Organization
Kidney Center, Tokyo Women's Medical University
Division name
Department of Medicine
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
yukko_iwa_010005@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuk Iwabuchi |
Organization
Kidney Center, Tokyo Women's Medical University
Division name
Department of Medicine
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
Homepage URL
yukko_iwa_010005@yahoo.co.jp
Sponsor or person
Institute
Department of Medicine, Kidney Center,
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine, Kidney Center,
Tokyo Women's 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
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2011 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 10 | Day |
Last modified on
| 2016 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006223
