UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014895 |
|---|---|
| Receipt number | R000017325 |
| Scientific Title | Rituximab and methylprednisolone pulse therapy for childhood-onset, complicated, steroid-resistant nephrotic syndrome: a prospective multicenter trial (JSKDC08) |
| Date of disclosure of the study information | 2014/08/20 |
| Last modified on | 2019/09/12 09:58:21 |
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Basic information
Public title
Rituximab and methylprednisolone pulse therapy for childhood-onset, complicated, steroid-resistant nephrotic syndrome: a prospective multicenter trial (JSKDC08)
Acronym
Rituximab and methylprednisolone pulse therapy for childhood-onset, complicated, steroid-resistant nephrotic syndrome: a prospective multicenter trial (JSKDC08)
Scientific Title
Rituximab and methylprednisolone pulse therapy for childhood-onset, complicated, steroid-resistant nephrotic syndrome: a prospective multicenter trial (JSKDC08)
Scientific Title:Acronym
Rituximab and methylprednisolone pulse therapy for childhood-onset, complicated, steroid-resistant nephrotic syndrome: a prospective multicenter trial (JSKDC08)
Region
| Japan |
Condition
Condition
childhood-onset, complicated,
steroid-resistant nephrotic syndrome
Classification by specialty
| Nephrology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of rituximab and methylprednisolone pulse therapy for childhood-onset, complicated, steroid-resistant nephrotic syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete remission rate at month 6
Key secondary outcomes
Time to complete remission, Partial remission rate, CKD rate, Urinary protein to creatinine ratio, Estimated glomerular filtration rate, B cell depletion period
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
Rituximab and methylprednisolone pulse therapy
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 under 18 years of age, and 2 years of age or older at assignment.
3.Patients who have received these 1) and 2) within 1 year prior to assignment.
1) CNI(cyclosporine or taclorimus) over four months
2) Methylprednisolone pulse therapy (more than three times to 12 times)
4. Urinary protein to creatinine ratio is over 2.0 g/gCr and Serum albumin is under 3.0 g/dL
5. Patients in whom 5/microL or more CD20-positive cells are observed in the peripheral blood.
6. Patients who can be hospitalized overnight on the first day of rituximab administration.
7. Written informed consent.
Key exclusion criteria
1.History of nephritic-NS, such as IgA nephropathy prior to assignment or in whom secondary NS is suspected.
2.Patients who have been detected gene abnormality(NPHS2,WT1)or in whom gene abnormality(NPHS2,WT1)is suspected.
3.History of receiving rituximab within 1 years prior to assignment.
4.History of receiving any kinds of monoclonal antibody therapy.
5.Having received a new immunosuppressant within 4 weeks prior to assignment.
6.Patients meeting either one of the following infection:
1)Presence or history of severe infections within 6 months prior to assignment.
2)Presence or history of opportunistic infections within 6 months prior to assignment.
3)Presence of active tuberculosis.
4)Patients with a history of tuberculosis or in whom tuberculosis is suspected.
5)Presence or history of active Hepatitis B or Hepatitis C or hepatitis B virus carrier.
6)Presence of HIV infection.
7.Presence or history of angina pectoris, cardiac failure, myocardial infarction, or serious arrhythmia (findings observed under Grade 4 of the CTCAE v4.0-JCOG.
8.Presence or history of auto-immune diseases or vascular purpura.
9.Presence or history of malignant tumor.
10.History of organ transplantation.
11.History of drug allergies to methylprednisolone, acetaminophen, or d-chlorpheniramine maleate.
12.Uncontrollable hypertension.
13.Deteriorated kidney function, e.g. eGFR<45 mL/min./1.73m2.
14.Having received a live vaccine within 4 weeks prior to assignment.
15.Patients showing either one of the following abnormal clinical laboratory value:
1)WBC <3,000/microL.
2)neutrophil <1,500/microL.
3)PLT <50,000/microL.
4)ALT >2.5 x upper limit of normal value.
5)AST >2.5 x upper limit of normal value.
6)Positive for HBsAg, HBsAb, HBcAb and HCVAb.
7)Positive for HIV antibody.
16. Patients who do not agree with contraception during the study period.
17.Women during pregnancy or breast-feeding.
18.Judged inappropriate for this study by the physicians.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Kamei |
Organization
National Center for Child Health and Development
Division name
Division of Nephrology and Rheumatology
Zip code
157-8535
Address
2-10-1 Ookura, Setagaya-ku, Tokyo
TEL
03-3416-0181
kamei-k@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Sako |
Organization
National Center for Child Health and Development
Division name
Division for Clinical Trials
Zip code
157-8535
Address
2-10-1 Ookura, Setagaya-ku, Tokyo
TEL
03-3416-0181
Homepage URL
sako-m@ncchd.go.jp
Sponsor or person
Institute
Japanese Study Group of Kidney Disease in Children
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB in National Center for Child Heath and Development
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
Tel
03-3416-0181
kenkyu-ncchd@ncchd.go.jp
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 | 08 | Month | 20 | 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
| 2014 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 19 | Day |
Last modified on
| 2019 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017325
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| Registered date | File name |
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