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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014355
Receipt No. R000016672
Scientific Title Uncontrolled trial of Rituximab treatment on refractory or steroid dependent nephrotic syndrome in adult.
Date of disclosure of the study information 2014/07/01
Last modified on 2018/10/13

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Basic information
Public title Uncontrolled trial of Rituximab treatment on refractory or steroid dependent nephrotic syndrome in adult.
Acronym Uncontrolled trial of Rituximab treatment on refractory or steroid dependent nephrotic syndrome in adult.
Scientific Title Uncontrolled trial of Rituximab treatment on refractory or steroid dependent nephrotic syndrome in adult.
Scientific Title:Acronym Uncontrolled trial of Rituximab treatment on refractory or steroid dependent nephrotic syndrome in adult.
Region
Japan

Condition
Condition refractory or steroid dependent 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 refractory or steroid dependent nephrotic syndrome.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Remission rate
Relapse rate
The cumulative dose of prednisolone
and immunosuppressive drug
Key secondary outcomes The adverse effect of prednisolone.
The adverse effect of immunosuppressive drug
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

Not applicable
Gender Male and Female
Key inclusion criteria Refractory nephrotic syndrome patients.
Steroid dependent nephrotic syndrome patients.
Patients gave written informed consent for participation in the study
Key exclusion criteria Positive serology for hepatitis B, Cardiac failure, Lung dysfunction, Bone marrow dysfunction, Pregnant subjects or subjects who do not agree with contraception during the study period
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirokazu Okada
Organization Saitama Medical University
Division name Department of Nephrology
Zip code
Address 38 Morohongo, Moroyamamachi, Iruma-gun Saitama 350-0495, Japan
TEL 049-276-1612
Email hirookda@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Watanabe
Organization Saitama Medical University
Division name Department of Nephrology
Zip code
Address 38 Morohongo, Moroyamamachi, Iruma-gun Saitama 350-0495, Japan
TEL 049-276-1612
Homepage URL
Email yusuke_w@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University Department of Nephrology
Institute
Department

Funding Source
Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 01 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 Completed
Date of protocol fixation
2014 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 23 Day
Last modified on
2018 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016672

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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