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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022150
Receipt No. R000025524
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.
Date of disclosure of the study information 2016/05/01
Last modified on 2020/05/05

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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/ctr_e/ctr_view.cgi?recptno=R000025524

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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