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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041475
Receipt No. R000046293
Scientific Title Rituximab on Adult-onset frequenTly rElApsing or steroid dependent nephrotic syndrome study
Date of disclosure of the study information 2020/10/01
Last modified on 2021/02/04

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Basic information
Public title Rituximab on Adult-onset frequenTly rElApsing or steroid dependent nephrotic syndrome study
Acronym A-TEAM study
Scientific Title Rituximab on Adult-onset frequenTly rElApsing or steroid dependent nephrotic syndrome study
Scientific Title:Acronym A-TEAM study
Region
Japan

Condition
Condition adult-onset frequently relapsing or
steroid dependent nephrotic syndrome
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 IDEC-C2B8 375 mg / m2 / dose was administered twice at 1-week intervals to patients with adult-onset nephrotic syndrome (frequently relapsing or steroid-dependent), and 24 weeks after the first dose of IDEC-C2B8. The efficacy and safety of IDEC-C2B8 375 mg / m2 will be examined.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cumulative recurrence-free rate at 48 weeks from the start of study drug administration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 IDEC-C2B8
Interventions/Control_2 control
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 Patients diagnosed with frequent relapsing type or steroid-dependent nephrotic syndrome in the past, and remission (urine protein <0.3 g / gCr) was confirmed by urine protein quantification more than twice after the start of steroid treatment for the latest recurrence
Key exclusion criteria 1. Patients with secondary nephrotic syndrome (including suspicion)
2. Patients who have been treated with rituximab
3.Patients with eGFR of 44mL / min / 1.73m2 or less
4.Patients with an infectious disease
Target sample size 64

Research contact person
Name of lead principal investigator
1st name YOSHITAKA
Middle name
Last name ISAKA
Organization Osaka University Graduate School of Medicine
Division name Division of Nephrology
Zip code 5650871
Address 2-2, Yamada-oka, Suita
TEL 0668793857
Email isaka@kid.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name YOSHITAKA
Middle name
Last name ISAKA
Organization Osaka University Graduate School of Medicine
Division name Division of Nephrology
Zip code 5650871
Address 2-2, Yamada-oka, Suita
TEL 0668793857
Homepage URL
Email isaka@kid.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization ZENYAKU KOGYO
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Department of Medical Innovation
Address 2-2, Yamada-oka, Suita
Tel 0662108289
Email Ueshima@dmi.med.osaka-u.ac.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
2020 Year 10 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 Open public recruiting
Date of protocol fixation
2020 Year 08 Month 04 Day
Date of IRB
2020 Year 08 Month 07 Day
Anticipated trial start date
2020 Year 09 Month 23 Day
Last follow-up date
2023 Year 08 Month 31 Day
Date of closure to data entry
2024 Year 03 Month 31 Day
Date trial data considered complete
2024 Year 03 Month 31 Day
Date analysis concluded
2024 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2020 Year 08 Month 20 Day
Last modified on
2021 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046293

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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