UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021143 |
|---|---|
| Receipt number | R000024391 |
| Scientific Title | A study of the efficacy and safety to rituximab in treating adult onset refractory nephrotic syndrome |
| Date of disclosure of the study information | 2016/02/23 |
| Last modified on | 2017/06/24 11:47:30 |
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Basic information
Public title
A study of the efficacy and safety to rituximab in treating adult onset refractory nephrotic syndrome
Acronym
Rituximab to refractory nephrotic syndrome
Scientific Title
A study of the efficacy and safety to rituximab in treating adult onset refractory nephrotic syndrome
Scientific Title:Acronym
Rituximab to refractory nephrotic syndrome
Region
| Japan |
Condition
Condition
Refractory nephrotic syndrome
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety to rituximab in treatinb adult onset refractory nephrotic syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The dose of glucocorticoids and immunosuppressive drugs after 3 months
Key secondary outcomes
1. number of relapses per person-year
2. Urinary protein and serum albumin
(3 months and 1 year
3. The dose of glucocorticoids and immunosuppressive drugs after 1 year
4. Severe adverse events during 1 year
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
an intravenous dose of 375 mg per 1 square meter (maximum 500 mg) once weekly for 4 weeks.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Steroid dependent nephrotic syndrome
2. Frequently relapsing nephrotic syndrome
3. Refractory nephrotic syndrome
Key exclusion criteria
1. Severe hypersensitivity to the component of rituximab or products derived from mouse protein.
2. Positive serology for HBs antigen or HBv-DNA
3. Active infection
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Midori Hasegawa |
Organization
Fujita Health University School f Medicine
Division name
Department of Nephrology
Zip code
Address
1-98 Dengakugakubo Kutsukakecho Toyoakeshi
TEL
0562-93-9256
mhase@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hasegawa Midori |
Organization
Fujita Health University School of Medicine
Division name
Department of Nephrology
Zip code
Address
1-98 Dengakugakubo Kutsukakecho Toyoakeshi
TEL
0562-93-9245
Homepage URL
mhase@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine, Department of Nephrology
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2016 | Year | 02 | Month | 23 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 29 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 29 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 29 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 29 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 22 | Day |
Last modified on
| 2017 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024391
