UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049132 |
|---|---|
| Receipt number | R000055961 |
| Scientific Title | JP-SHINE study: Pediatric Idiopathic Nephrotic Syndrome Registry |
| Date of disclosure of the study information | 2022/12/31 |
| Last modified on | 2023/08/03 08:15:03 |
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Basic information
Public title
JP-SHINE study: Pediatric Idiopathic Nephrotic Syndrome Registry
Acronym
JP-SHINE study: Pediatric Idiopathic Nephrotic Syndrome Registry
Scientific Title
JP-SHINE study: Pediatric Idiopathic Nephrotic Syndrome Registry
Scientific Title:Acronym
JP-SHINE study: Pediatric Idiopathic Nephrotic Syndrome Registry
Region
| Japan |
Condition
Condition
infantile idiopathic nephrotic syndrome
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
A registry will be established for patients with the intractable pediatric idiopathic nephrotic syndrome, and long-term observation will be conducted to clarify the actual treatment status and long-term prognosis of the disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of cases that progressed to refractory nephrotic syndrome as a percentage of total enrollment
Time to refractoriness
Key secondary outcomes
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
| 6 | months-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients newly diagnosed with pediatric idiopathic nephrotic syndrome after approval by the Ethics Committee (including patients transferred to the hospital before (or during) the initial treatment)
(2) 999 patients enrolled in an existing study (JP-SHINE Study)
(3) Patients aged between 6 months and 15 years at the time of diagnosis
Key exclusion criteria
(i) Patients deemed inappropriate for this study by the physician in charge
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Ishikura |
Organization
Kitasato University
Division name
Faculty of Medicine
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL
042-778-8111
info@pckd.jpn.org
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Kikunaga |
Organization
Kitasato University
Division name
Faculty of Medicine
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL
042-778-8111
Homepage URL
info@pckd.jpn.org
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
Tel
042-778-8111
info@pckd.jpn.org
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
| 2022 | Year | 12 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2022 | Year | 10 | Month | 06 | Day |
Last modified on
| 2023 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055961
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
