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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001406
Receipt No. R000001710
Scientific Title Pharmacokinetic 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

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Basic information
Public title Pharmacokinetic Study of IDEC-C2B8
in Patients with Childhood-onset Refractory Nephrotic Syndrome
Acronym Pharmacokinetic Study of IDEC-C2B8
(RCRNS02)
Scientific Title Pharmacokinetic Study of IDEC-C2B8
in Patients with Childhood-onset Refractory Nephrotic Syndrome
Scientific Title:Acronym Pharmacokinetic Study of IDEC-C2B8
(RCRNS02)
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 pharmacokinetic profiles of IDEC-C2B8 in patients with childhood-onset refractory nephrotic syndrome.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Investigation of pharmacokinetic profiles
Key secondary outcomes

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 IDEC-C2B8
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
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. The first onset of INS is between 1 - 18 years of age, and 2 years of age or older at entry
3. Subjects meeting either one of the following criteria:
1) having relapsed within 85 days (during Day 1 to Day 85) after receiving "placebo" in the double blind study (a separate study with protocol # RCRNS-01)
2) having diagnosed as frequently relapsing and steroid-dependent INS (FR-SD INS) during the period of Day 86 though Day 365 after receiving the "placebo" in the double blind study (protocol # RCRNS-01)
3) with a history of IDEC-C2B8 treatment for INS in the year of 2007 or before
4. Diagnosed as steroid-sensitive relapse
5. CD20 positive B-cells >/= 5/mcL in the peripheral blood
6. Subjects can be hospitalized for treatments of study drug
7. 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 except for IDEC-C2B8
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 20

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
Email

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
Email rcrns@med.kobe-u.ac.jp

Sponsor
Institute Research group of Childhood-onset Refractory Nephrotic Syndrome
Institute
Department

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
Email

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 12 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001710

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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