UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of cyclosporine and steroid for the treatment of minimal change nephrotic syndrome
Title of the study (Brief title)	Cyclosporine for MCNS
Region	Japan

Condition
Condition	Minimal change nephrotic syndrome
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Safety and efficacy of cyclosporine for the patients with MCNS
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Rate for complete remission Total dose of steroid Duration of admission
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	administration of cyclosporine
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	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	MCNS patients proven by renal biopsy
Key exclusion criteria	Cr>=2.0mg/dl or eGFR<50 Malignancy Uncontrolled hypertension Seizure disorder Pregnant women Infection Severe cardiac, hepatic or pancreatic disease Alelrgy to cyclosporine
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshihiko Saito
Organization	Nara Medical University
Division name	1st Dept Intern Med
Address	840 Shijo, Kasihara Nara
TEL
Email

Public contact
Name of contact person
Organization	Nara Medical University
Division name	1st Dept Intern Med
Address
TEL	0744-22-3051
Homepage URL
Email

Sponsor
Institute	Yoshihiko Saito
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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	2010 Year 01 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 09 Month 28 Day
Anticipated trial start date	2007 Year 10 Month 01 Day
Last follow-up date	2010 Year 10 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2008 Year 01 Month 03 Day
Last modified on	2017 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001160