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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014347
Receipt No. 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 2019/12/27

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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
Email 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
Email sako-m@ncchd.go.jp

Sponsor
Institute Japanese Study Group of Kidney Disease in Children
Institute
Department

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
Email 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 No longer recruiting
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
2019 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016599

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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