UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001405 |
|---|---|
| Receipt number | R000001680 |
| Scientific Title | A Phase III, Double-Blind, Randomized Study of IDEC-C2B8 in Patients with Childhood-onset Refractory Nephrotic Syndrome |
| Date of disclosure of the study information | 2008/10/02 |
| Last modified on | 2014/06/02 19:12:33 |
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Basic information
Public title
A Phase III, Double-Blind, Randomized Study of IDEC-C2B8 in Patients with Childhood-onset Refractory Nephrotic Syndrome
Acronym
Double-Blind Study of IDEC-C2B8 (RCRNS01)
Scientific Title
A Phase III, Double-Blind, Randomized Study of IDEC-C2B8 in Patients with Childhood-onset Refractory Nephrotic Syndrome
Scientific Title:Acronym
Double-Blind Study of IDEC-C2B8 (RCRNS01)
Region
| Japan |
Condition
Condition
Childhood-onset Refractory Nephrotic Syndrome
Classification by specialty
| Nephrology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of IDEC-C2B8 in comparison with placebo as measured by relapse-free duration in patients with childhood-onset refractory nephritic syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
relapse-free duration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
IDEC-C2B8
Interventions/Control_2
placebo
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
| 2 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed as idiopathic nephrotic syndrome (INS) according to the ISKDC criteria.
2. Subjects meeting either one of the following criteria:
1) Diagnosed as frequently relapsing or steroid-dependent INS again after immunosuppressant treatment such as cyclosporine A, cyclophosphamide and/or mizoribine for previous frequently relapsing or steroid-dependent NS.
2) Diagnosed as frequently relapsing or steroid-dependent INS during immunosuppressant treatment such as cyclosporine A, cyclophosphamide and/or mizoribine for previous frequently relapsing or steroid-dependent NS.
3) Diagnosed as frequently relapsing or steroid-dependent INS after or during treatment with cyclosporine A alone or in combination with methylprednisolone for previous steroid-resistant NS which was initially diagnosed as NS.
3. First onset of INS is between 1 - 18 years of age, and 2 years of age or older at entry.
4. Subjects with records of nearest preceding 3 relapses
5. Diagnosed as steroid-sensitive relapse
6.CD20 positive B-cells >/= 5/mcL in the peripheral blood
7. Subjects can be hospitalized for treatments
8. Subjects have ability to provide written informed consent form. The written informed consent form of legal representative (i.e., a parent or a legal benefactor) is also required for subjects less than 20 years of age.
Key exclusion criteria
1. History of inflammatory nephritis such as IgA nephritis.
2. History of immunosuppressive treatment for INS other than cyclosporine A, tacrolimus, cyclophosphamide, mizoribine, azathioprine, mycophenolate mofetil and chlorambucil
3. History of serious infectious diseases such as pulmonary tuberculosis and deep-seated fungal diseases
4. Positive for HCV antibody, HBs antigen, HBc antibody and HIV antibody
5. Having received a live vaccine within 4 weeks prior to screening
6.Known hypertension which is uncontrollable with conventional anti-hypertensive
7. Deteriorated kidney function, e.g. estimated GFR<60mL/min./1.73m2
8. Deteriorated liver function, e.g., AST or ALT > 2.5 x upper limit of normal value
9. Presence or history of angina pectoris, cardiac failure, myocardial infarction and/or serious arrhythmia grade 4 in "Common Terminology Criteria for Adverse Events (ver. 3.0)"
10. Presence or history of auto-immune diseases such as Hashimoto disease (struma lymphomatosa), Crohn's disease, ulcerative colitis, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma or vascular purpura
11. Presence or history of cancer
12. History of organ transplantation
13. History of allergic reaction to methylprednisolone, acetaminophen and/or d-chlorpheniramine maleate
14. Presence of hematological disorder, e.g., WBC < 2,000/mcL, neutrophil < 1,500/mcL, PLT < 50,000/mcL
15. History of receiving any kinds of monoclonal antibody therapy
16. Having received any investigational agent within 6 months prior to enrollment, or participating other clinical studies
17. Pregnant subjects or subjects who do not agree with contraception during the study period (Negative HCG result is required at screening for female subjects after the first menstruation.)
18.Judged inappropriate for this study by the physicians
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazumoto Iijima |
Organization
Division of Child Health and Development
Department of Pediatrics
Kobe University Graduate School of medicine
Division name
Department of Pediatrics
Zip code
Address
5-1 Kusunoki-cho 7 chome
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University Hospital
Division name
Research group of Childhood-onset Refractory Nephrotic Syndrome
Zip code
Address
TEL
Homepage URL
rcrns@med.kobe-u.ac.jp
Sponsor or person
Institute
Research group of Childhood-onset Refractory Nephrotic Syndrome
Institute
Department
Personal name
Funding Source
Organization
Center for Clinical Trials, Japan Medical Association
Organization
Division
Category of Funding Organization
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
| 2008 | Year | 10 | Month | 02 | 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
| 2008 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 12 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 10 | Month | 01 | Day |
Last modified on
| 2014 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001680
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