UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017470 |
|---|---|
| Receipt number | R000020246 |
| Scientific Title | Study on the effect of rituximab for steroid-dependent nephrotic syndrome |
| Date of disclosure of the study information | 2015/05/08 |
| Last modified on | 2015/05/08 18:45:25 |
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Basic information
Public title
Study on the effect of rituximab for steroid-dependent nephrotic syndrome
Acronym
R-SDNS Study
Scientific Title
Study on the effect of rituximab for steroid-dependent nephrotic syndrome
Scientific Title:Acronym
R-SDNS Study
Region
| Japan |
Condition
Condition
steroid-dependent nephrotic syndrome
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine of the effect and safety of rituximab for steroid-dependent nephrotic syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of remission
Key secondary outcomes
Base
Study type
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
Administration of rituximab
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
| 16 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patietns with primary nephrotic syndrome
2. Patients who had a history of frequent relapse
3. Patients who provided written informed consent for participating this study.
Key exclusion criteria
1. Patients who had a history of severe anaphylactic reaction
2. Patients with severe heart disease, hepatic dysfunction and respiratory dysfunction
3. Patients with hepatitis B virus carrier or infection
4. Patients who are pregnant or lactating
5. Patients who are not eligible for this study at the discretion of the investigator
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanari Kitazono |
Organization
Graduate School Medical Sciences, Kyushu University
Division name
Department of Medicine and Clinical Science
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5250
kitazono@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Tsuruya |
Organization
Graduate School Medical Sciences, Kyushu University
Division name
Department of Integrated Therapy for Chronic Kidney Disease
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5843
Homepage URL
tsuruya@intmed2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate School Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Graduate School Medical Sciences, Kyushu University
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 05 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | 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
| 2015 | Year | 05 | Month | 08 | Day |
Last modified on
| 2015 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020246
