UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005231
Receipt No. 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

* 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&#39;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
Email 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&#39;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
Email yukko_iwa_010005@yahoo.co.jp

Sponsor
Institute Department of Medicine, Kidney Center,
Tokyo Women&#39;s Medical University
Institute
Department

Funding Source
Organization Department of Medicine, Kidney Center,
Tokyo Women&#39;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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006223

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.