UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long-term outcome study of patients with refractory nephrotic syndrome after multicenter, double blind, randomized, placebo-controlled trial of rituximab
Title of the study (Brief title)	Long-term outcome study of patients with nephrotic syndrome treated with rituximab
Region	Japan

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

Objectives
Narrative objectives1	To investigate the long-term outcome of patients with refractory nephrotic syndrome after multicenter, double blind, randomized, placebo-controlled trial of rituximab.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	First relapse after rituximab treatment
Key secondary outcomes	1. Administration of immunosuppressive agents after rituximab treatment 2. Re-treatment of rituximab 3. Late onset adverse events after rituximab treatment

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with refractory nephrotic syndrome who was enrolled in the multicenter, double blind, randomized, placebo-controlled trial of rituximab
Key exclusion criteria	Patients who did not participate in the trial
Target sample size	58

Research contact person
Name of lead principal investigator	Koichi Kamei
Organization	National Center for Child Health and Development
Division name	Nephrology and Rheumatology
Address	2-10-1, Okura, Setagaya-ku, Tokyo
TEL	03-5494-7128
Email	kamei-k@ncchd.go.jp

Public contact
Name of contact person	Koichi Kamei
Organization	National Center for Child Health and Development
Division name	Nephrology and Rheumatology
Address	2-10-1, Okura, Setagaya-ku, Tokyo
TEL	03-5494-7128
Homepage URL
Email	kamei-k@ncchd.go.jp

Sponsor
Institute	Non-Profit Organization Japan Clincal Research Support Unit
Institute
Department

Funding Source
Organization	Japan Medical Association Center for Clinical Trials
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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 09 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 18 Day
Anticipated trial start date	2014 Year 09 Month 21 Day
Last follow-up date	2016 Year 10 Month 01 Day
Date of closure to data entry	2016 Year 10 Month 01 Day
Date trial data considered complete	2016 Year 12 Month 01 Day
Date analysis concluded	2017 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We will soon start retrospective cohort study of enrolled 58 patients.

Management information
Registered date	2014 Year 09 Month 22 Day
Last modified on	2017 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017696