UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the efficacy and safety to rituximab in treating adult onset refractory nephrotic syndrome
Title of the study (Brief title)	Rituximab to refractory nephrotic syndrome
Region	Japan

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

Objectives
Narrative objectives1	To clarify the efficacy and safety to rituximab in treatinb adult onset refractory nephrotic syndrome
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The dose of glucocorticoids and immunosuppressive drugs after 3 months
Key secondary outcomes	1. number of relapses per person-year 2. Urinary protein and serum albumin (3 months and 1 year 3. The dose of glucocorticoids and immunosuppressive drugs after 1 year 4. Severe adverse events during 1 year

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	an intravenous dose of 375 mg per 1 square meter (maximum 500 mg) once weekly for 4 weeks.
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	1. Steroid dependent nephrotic syndrome 2. Frequently relapsing nephrotic syndrome 3. Refractory nephrotic syndrome
Key exclusion criteria	1. Severe hypersensitivity to the component of rituximab or products derived from mouse protein. 2. Positive serology for HBs antigen or HBv-DNA 3. Active infection
Target sample size	10

Research contact person
Name of lead principal investigator	Midori Hasegawa
Organization	Fujita Health University School f Medicine
Division name	Department of Nephrology
Address	1-98 Dengakugakubo Kutsukakecho Toyoakeshi
TEL	0562-93-9256
Email	mhase@fujita-hu.ac.jp

Public contact
Name of contact person	Hasegawa Midori
Organization	Fujita Health University School of Medicine
Division name	Department of Nephrology
Address	1-98 Dengakugakubo Kutsukakecho Toyoakeshi
TEL	0562-93-9245
Homepage URL
Email	mhase@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University School of Medicine, Department of Nephrology
Institute
Department

Funding Source
Organization	None
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	2016 Year 02 Month 23 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 02 Month 22 Day
Anticipated trial start date	2016 Year 02 Month 29 Day
Last follow-up date	2017 Year 04 Month 29 Day
Date of closure to data entry	2017 Year 04 Month 29 Day
Date trial data considered complete	2017 Year 04 Month 29 Day
Date analysis concluded	2017 Year 04 Month 29 Day

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

Management information
Registered date	2016 Year 02 Month 22 Day
Last modified on	2017 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024391