UMIN-CTR Clinical Trial

Basic information
Public title	The prospective single-center study on the efficacy and safety of rituximab for the treatment of adult and geriatric patients with primary nephrotic syndrome.
Acronym	The study on efficacy and safety of rituximab for adult and geriatric patients with nephrotic syndrome.
Scientific Title	The prospective single-center study on the efficacy and safety of rituximab for the treatment of adult and geriatric patients with primary nephrotic syndrome.
Scientific Title:Acronym	The study on efficacy and safety of rituximab for adult and geriatric patients with nephrotic syndrome.
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to clarify the efficacy and safety of rituximab for adult and geriatric nephrotic patient.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Rate of remission from nephrotic syndrome
Key secondary outcomes	1.Rate of continuity of the selected treatment. 2. The reduction of the degree of proteinuria. 3. Frequency of adverse complication derived from drug use. 4. Total dose of prednisolone and immunosuppressant agents for treatment of nephrotic syndrome. 5. Changes in the renal function

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
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient whose age is more than 18 years old, and who is established the diagnosis of primary nephrotic syndrome.
Key exclusion criteria	Case that showed at least one of the following terms should be excluded. 1)Patient who have the severe allergy for rituximab. 2)Patient who has the severe disease, such as heart failure,liver diseases(hepatitis B positive)and end stage renal disease. 3)Patient who has the severe bacterial,fungal or viral infection. 4)Patient who could not experienced informd consent. 5)The doctor decides that the patient is inappropriate to enroll in this study.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Takasi Middle name Last name Takei
Organization	Tokyo Metropolitan Geriatric Hospital
Division name	Nephrology
Zip code	1730015
Address	35-2, Sakae-cho, Itabashi-ku, Tokyo, Japan
TEL	03-3964-1982
Email	takashi_takei@tmghig.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Takei
Organization	Tokyo Metropolitan Geriatric Hospital
Division name	Nephrology
Zip code	1730015
Address	35-2, Sakae-cho, Itabashi-ku, Tokyo, Japan
TEL	03-3964-1982
Homepage URL
Email	takashi_takei@tmghig.jp

Sponsor
Institute	Tokyo Metropolitan Geriatric Hospital
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Geriatric Hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyo Metropolitan Geriatric Hospital
Address	35-2, Sakae-cho, Itabashi-ku, Tokyo, Japan
Tel	03-3964-1982
Email	takashi_takei@tmghig.jp

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 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 15 Day
Date of IRB	2016 Year 05 Month 13 Day
Anticipated trial start date	2016 Year 04 Month 30 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 04 Month 30 Day
Last modified on	2020 Year 05 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025524