UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Uncontrolled trial of Rituximab treatment on refractory or steroid dependent nephrotic syndrome in adult.
Title of the study (Brief title)	Uncontrolled trial of Rituximab treatment on refractory or steroid dependent nephrotic syndrome in adult.
Region	Japan

Condition
Condition	refractory or steroid dependent nephrotic syndrome
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effects and safety of rituximab in adult patients with refractory or steroid dependent nephrotic syndrome.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Remission rate Relapse rate The cumulative dose of prednisolone and immunosuppressive drug
Key secondary outcomes	The adverse effect of prednisolone. The adverse effect of immunosuppressive drug The adverse effect of rituximab

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 375mg/m2 single-dose 1 time/6months 24 months follow up
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Refractory nephrotic syndrome patients. Steroid dependent nephrotic syndrome patients. Patients gave written informed consent for participation in the study
Key exclusion criteria	Positive serology for hepatitis B, Cardiac failure, Lung dysfunction, Bone marrow dysfunction, Pregnant subjects or subjects who do not agree with contraception during the study period
Target sample size	5

Research contact person
Name of lead principal investigator	Hirokazu Okada
Organization	Saitama Medical University
Division name	Department of Nephrology
Address	38 Morohongo, Moroyamamachi, Iruma-gun Saitama 350-0495, Japan
TEL	049-276-1612
Email	hirookda@saitama-med.ac.jp

Public contact
Name of contact person	Yusuke Watanabe
Organization	Saitama Medical University
Division name	Department of Nephrology
Address	38 Morohongo, Moroyamamachi, Iruma-gun Saitama 350-0495, Japan
TEL	049-276-1612
Homepage URL
Email	yusuke_w@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University Department of Nephrology
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	2014 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 02 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date
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	2014 Year 06 Month 23 Day
Last modified on	2018 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016672