UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cyclosporine C2 monitaring for frequently relapsing nephrotic syndrome in children: A randomized controlled trial
Title of the study (Brief title)	Cyclosporine C2 monitaring: A randomized controlled trial(JSKDC03)
Region	Japan

Condition
Condition	Frequently relapsing nephrotic syndrome in children
Classification by specialty	Nephrology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	By comparing two target cyclosporine C2 levels,the better is selected as a standard treatment for frequently relapsing nephrotic syndrome in children in our group.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relapse-free rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Cyclosporine C2 monitoring with higher target levels
Interventions/Control_2	Cyclosporine C2 monitoring by lower target levels
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	1 years-old <=
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Primary nephrotic syndrome (proteinuria with a urinary protein-creatinine ratio >1.8 and hypoalbuminemia with serum albumin level <2.5 g/dL). 2.Frequently relapse or steroid independence, based on the International study of kidney disease in children. 3.Biopsy diagnoses of MCNS, MPGN or FSGS, where a renal biopsy has been performed within 12 months before eligibility. 4.Aged twelve months to 18 years. 5.Written informed consent from the patients' parents or legal guardians.
Key exclusion criteria	1.Other renal or systemic forms of nephrotic syndrome defined on renal biopsy, clinical features or serology (Henoch-Sch&ouml;nlein nephritis, systemic lupus erythematosus). 2.History of steroid resistance. 3.Medical history of allergy or hypersensitivity reactions to cyclosporine. 4.Poorly controlled hypertension. 5.Chronic renal dysfunction. 6.Active infectious disease. 7.Severe liver disfunction. 8.History of cyclosporine administration. 9.Pregnancy. 10.Judged inappropriate for this study by the physicians.
Target sample size	100

Research contact person
Name of lead principal investigator	Kazumoto Iijima
Organization	Division of Child Health and Development Kobe University Graduate School of medicine
Division name	Department of Pediatrics
Address	5-1 Kusunoki-cho 7 chome Kobe City
TEL	078-382-6093
Email	iijima@med.kobe-u.ac.jp

Public contact
Name of contact person	Nakanishi
Organization	Japanese Study Group of Kidney Disease in Children
Division name	Department of Pediatrics, Wakayama Medical University
Address	811-1 KImiidera Wakayama City
TEL	073-441-0633
Homepage URL
Email	jskdc@wakayama-med.ac.jp

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

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2005 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 04 Month 25 Day
Anticipated trial start date	2005 Year 04 Month 01 Day
Last follow-up date	2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2005 Year 06 Month 14 Day
Last modified on	2016 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000011