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

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome

Classification by specialty

Nephrology Pediatrics

Classification by malignancy

Others

Genomic information

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

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

Concealment

Central registration

Intervention

No. of arms

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

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 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

Email

cerb@med.kobe-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name