UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001406
Receipt number 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 19:13:09

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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 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


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

Value
https://center6.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