UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015220 |
|---|---|
| Receipt number | R000017696 |
| Scientific Title | Long-term outcome study of patients with refractory nephrotic syndrome after multicenter, double blind, randomized, placebo-controlled trial of rituximab |
| Date of disclosure of the study information | 2014/09/22 |
| Last modified on | 2017/03/25 10:12:24 |
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Basic information
Public title
Long-term outcome study of patients with refractory nephrotic syndrome after multicenter, double blind, randomized, placebo-controlled trial of rituximab
Acronym
Long-term outcome study of patients with nephrotic syndrome treated with rituximab
Scientific Title
Long-term outcome study of patients with refractory nephrotic syndrome after multicenter, double blind, randomized, placebo-controlled trial of rituximab
Scientific Title:Acronym
Long-term outcome study of patients with nephrotic syndrome treated with rituximab
Region
| Japan |
Condition
Condition
refractory nephrotic syndrome
Classification by specialty
| Nephrology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the long-term outcome of patients with refractory nephrotic syndrome after multicenter, double blind, randomized, placebo-controlled trial of rituximab.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
First relapse after rituximab treatment
Key secondary outcomes
1. Administration of immunosuppressive agents after rituximab treatment
2. Re-treatment of rituximab
3. Late onset adverse events after rituximab treatment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with refractory nephrotic syndrome who was enrolled in the multicenter, double blind, randomized, placebo-controlled trial of rituximab
Key exclusion criteria
Patients who did not participate in the trial
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Kamei |
Organization
National Center for Child Health and Development
Division name
Nephrology and Rheumatology
Zip code
Address
2-10-1, Okura, Setagaya-ku, Tokyo
TEL
03-5494-7128
kamei-k@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Kamei |
Organization
National Center for Child Health and Development
Division name
Nephrology and Rheumatology
Zip code
Address
2-10-1, Okura, Setagaya-ku, Tokyo
TEL
03-5494-7128
Homepage URL
kamei-k@ncchd.go.jp
Sponsor or person
Institute
Non-Profit Organization Japan Clincal Research Support Unit
Institute
Department
Personal name
Funding Source
Organization
Japan Medical Association Center for Clinical Trials
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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 | 09 | Month | 22 | 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 | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 01 | Day |
Other
Other related information
We will soon start retrospective cohort study of enrolled 58 patients.
Management information
Registered date
| 2014 | Year | 09 | Month | 22 | Day |
Last modified on
| 2017 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017696
