UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041475 |
|---|---|
| Receipt number | 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 | 2026/02/25 21:50:34 |
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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
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
isaka@kid.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
https://jamanetwork.com/journals/jama/article-abstract/2841034
Publication of results
Published
Result
URL related to results and publications
https://jamanetwork.com/journals/jama/article-abstract/2841034
Number of participants that the trial has enrolled
72
Results
The relapse-free rate at week 49 was 87.4% in the rituximab group and 38.0% in the placebo group (P < .001 ). One of 18 secondary outcomes was statistically significant (favoring rituximab). The median relapse-free time in the rituximab group was greater than 49.0 weeks and in the placebo group was 30.8 weeks. A stratified Cox model showed a hazard ratio for relapse of 0.16 (95% CI, 0.05-0.46; P < .001) in the rituximab group compared with the placebo group.
Results date posted
| 2026 | Year | 02 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Multicenter, double-blind, randomized, placebo-controlled trial conducted at 13 centers in Japan. Adults with FRNS or SDNS who had urine protein of less than 0.3 g/gCr were enrolled between September 1, 2020, and June 28, 2022. Final follow-up occurred on March 15, 2024.
Participant flow
Patients were randomized to receive either intravenous rituximab, 375 mg/m2 (n = 36), or placebo (n = 36) at weeks 1, 2, and 25. Patients were followed up for 49 weeks.
Adverse events
The most common adverse effect was infusion reaction (13 [40.6%] in the rituximab group and 1 [2.9%] in the placebo group).
Outcome measures
The primary outcome was the proportion of patients who were free of relapse of nephrotic syndrome at 49-week follow-up. Relapse was defined as urine protein of at least 1 g/gCr on 2 consecutive measurements.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2026 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046293
