UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041479 |
|---|---|
| Receipt number | R000047351 |
| Scientific Title | A study of immune diversity in patients with adult-onset nephrotic syndrome (frequent relapses or steroid dependence) |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2022/08/22 09:51:44 |
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Basic information
Public title
A study of immune diversity in patients with adult-onset nephrotic syndrome (frequent relapses or steroid dependence)
Acronym
Repertoire study
Scientific Title
A study of immune diversity in patients with adult-onset nephrotic syndrome (frequent relapses or steroid dependence)
Scientific Title:Acronym
Repertoire study
Region
| Japan |
Condition
Condition
Adult-onset nephrotic syndrome (frequent relapses or steroid-dependent)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Nephrotic syndrome is a syndrome characterized by massive urinary protein leakage and hypoproteinemia (hypoalbumin) due to increased protein permeability caused by renal glomerular engagement disorders, and the cause of primary nephrotic syndrome is not known. Although steroids are the drug of choice for first-line treatment, many patients have relapsed, and the side effects of continuous steroids and concomitant use of immunosuppressive drugs are problematic. In this situation, the aim of this study is to explore and identify biomarkers for the etiology and clinical course of adult-onset nephrotic syndrome (frequent relapses or steroid-dependent) by means of immunodiversity analysis (TCR/BCR repatea analysis).Specifically, by using specimens from patients participating in a clinical trial (IDEC-C2B8-aNS1) of rituximab for the prevention of relapse in adult-onset nephrotic syndromes (frequent relapses or steroid dependence), we will search for and identify biomarkers related to the prediction of efficacy or the occurrence of adverse effects, as well as for the clinical course of the disease.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gene diversity of T cell receptor (TCR) and B cell receptor (BCR)at baseline or their changes during treatment.
Key secondary outcomes
Proportion of T cell subsets and B cell subsets at baseline or their changes during treatment.
Search for biomarkers.
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
| 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 syndrom
e (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 CO., LTD.
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 | 09 | 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
72
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 09 | 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
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted as an ancillary study to the IDEC-C2B8-aNS1 study; blood samples will be collected from subjects enrolled in the IDEC-C2B8-aNS1 study and an immunodiversity analysis (TCR/BCR repatriation analysis) will be performed in this study.
Management information
Registered date
| 2020 | Year | 08 | Month | 20 | Day |
Last modified on
| 2022 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047351
