UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014347 |
|---|---|
| Receipt number | R000016599 |
| Scientific Title | Mycophenolate mofetil for childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicentre, double-blind, randomised, placebo-controlled trial(JSKDC07) |
| Date of disclosure of the study information | 2014/06/23 |
| Last modified on | 2021/12/28 11:43:28 |
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Basic information
Public title
Mycophenolate mofetil for childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicentre, double-blind,
randomised, placebo-controlled trial(JSKDC07)
Acronym
Mycophenolate mofetil for childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicentre, double-blind,
randomised, placebo-controlled trial(JSKDC07)
Scientific Title
Mycophenolate mofetil for childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicentre, double-blind,
randomised, placebo-controlled trial(JSKDC07)
Scientific Title:Acronym
Mycophenolate mofetil for childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicentre, double-blind,
randomised, placebo-controlled trial(JSKDC07)
Region
| Japan |
Condition
Condition
Childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome
Classification by specialty
| Nephrology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of mycophenolate mofetil in comparison with placebo as measured by he time to treatment failure in patients with childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
The time to treatment failure
Key secondary outcomes
Relapse free period, Time to SDNS, Time to FRNS, Time to SRNS, B cell depletion period, Daily steroid dose
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
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rituximab and mycophenolate mofetil
Interventions/Control_2
rituximab and mycophenolate mofetil 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.The first onset of INS is between 1 - 18 years of age, and 2 years of age or older at assignment.
3.Patients meeting either one of the following criteria:
1) Diagnosed with frequent relapse or steroid dependence and once again diagnosed with frequent relapse or steroid dependence after completion of immunosuppressive drug therapy (cyclosporine, cyclophosphamide, or mizoribine, etc.).
2) Diagnosed with frequent relapse or steroid dependence and once again diagnosed with frequent relapse or steroid dependence during immunosuppressive drug therapy (cyclosporine, cyclophosphamide, or mizoribine, etc.).
3) Diagnosed with steroid resistance following the onset of INS anf diagnosed with frequent relapse or steroid dependence during or after the completion of immunosuppressive drug therapy (cyclosporine alone or combination of cyclosporine and methylprednisolone, etc.).
4.Patients with records of nearest preceding 3 relapses.
5.Patients in whom steroid sensitivity is observed during treatment of relapse immediately prior to assignment.
6.Patients in whom 5/microL or more CD20-positive cells are observed in the peripheral blood.
7.Patients who can be hospitalized overnight on the first day of rituximab administration.
8.Written informed consent.
Key exclusion criteria
1.Patients who have been diagnosed with nephritic-NS, such as IgA nephropathy prior to assignment or in whom secondary NS is suspected.
2.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.
3.Presence or history of angina pectoris, cardiac failure, myocardial infarction, or serious arrhythmia (findings observed under Grade 4 of the CTCAE v4.0-JCOG.
4.Presence or history of auto-immune diseases or vascular purpura.
5.Presence or history of malignant tumor.
6.History of organ transplantation.
7.History of drug allergies to methylprednisolone, acetaminophen, or d-chlorpheniramine maleate.
8.Uncontrollable hypertension.
9.Deteriorated kidney function, e.g. estimated GFR<60 mL/min./1.73m2.
10.Having received a live vaccine within 4 weeks prior to enrollment.
11.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 HBs antigen, HBs antibody, HBc antibody and HCV antibody.
7)Positive for HIV antibody.
12.Patients who do not agree with contraception during the study period.
13.Women during pregnancy or breast-feeding.
14.Judged inap.propriate for this study by the physicians.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazumoto |
| Middle name | |
| Last name | Iijima |
Organization
Kobe University Graduate School of medicine
Division name
Division of Child Health and Development
Zip code
650-0017
Address
5-1 Kusunoki-cho 7 chome
TEL
078-382-6093
iijima@med.kobe-u.ac.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
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Clinical Research Ethical Committee
Address
5-1 Kusunoki-cho 7 chome
Tel
078-382-6669
cerb@med.kobe-u.ac.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 | 06 | Month | 23 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 23 | Day |
Last modified on
| 2021 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016599
