UMIN-CTR Clinical Trial

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
Email	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
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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017325