UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014355 |
|---|---|
| Receipt number | 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 16:24:15 |
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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
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
yusuke_w@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Department of Nephrology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016672
