UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044307 |
|---|---|
| Receipt number | R000050538 |
| Scientific Title | Japanese Alport Syndrome Patients Registry |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2023/12/01 15:57:50 |
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Basic information
Public title
Japanese Alport Syndrome Patients Registry
Acronym
Alport Registry
Scientific Title
Japanese Alport Syndrome Patients Registry
Scientific Title:Acronym
Alport Registry
Region
| Japan |
Condition
Condition
Alport syndrome
Classification by specialty
| Medicine in general | Nephrology | Pediatrics |
| Ophthalmology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We collect background information, treatment information, and information on the long-term prognosis of patients who have been confirmed to have Alport syndrome by genetic or histopathological examination, and examine the natural course, treatment status and treatment effect, genotype-phenotype correlation, etc. will be investigated.
Basic objectives2
Others
Basic objectives -Others
Under the leadership of the Japanese Society of Pediatric Nephrology, we will build a high-quality registry that can evaluate the efficacy and safety of medicines in the future.
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Age at the start of renal replacement therapy.
Key secondary outcomes
1. Estimated glomerular filtration rate (eGFR)
2. Urine protein
3. Age at onset of deafness
4. Time to start renal replacement therapy
5. Time to onset of deafness
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with persistent hematuria who have been confirmed to have Alport syndrome by genetic or histopathological examination
2) Patients with persistent hematuria whose relatives have already been diagnosed with Alport syndrome by genetic or histopathological examination
Key exclusion criteria
1)Patients who have declined to provide their data when opting in consent or opting out consent
2)Patients who have only heterozygous mutations in the COL4A3 or COL4A4 gene, urinary findings are only hematuria and no proteinuria, renal function is normal, and family history also shows only hematuria.
* To date, the definition of basement membrane thinning syndrome has not been determined, but in this study, such cases are treated as basement membrane thinning syndrome.
** As shown in the selection criteria 2), if there is a patient in the family who has urinary protein or renal dysfunction and is diagnosed with autosomal dominant Alport syndrome, hematuria-only patients are also enrolled. If you are uncertain about your decision, consult with the research office.
3) Patients judged to be inappropriate as a target by the judgment of researchers.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kandai |
| Middle name | Nozu |
| Last name | Nozu |
Organization
Kobe University
Division name
Pediatrics
Zip code
650-0017
Address
7-5-1 Kusunokicho Chuouku Kobe
TEL
0783826090
nozu@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Motohiro |
| Middle name | |
| Last name | Sakamine |
Organization
Translational Research Center for Medical Innovation
Division name
Study Management Group
Zip code
650-0047
Address
Minatojimaminamimachi 1-5-4, Chuo-ku, Kobe-shi, Hyogo 650-0047 Japan
TEL
078-304-6802
Homepage URL
https://ctportal.tri-kobe.org/studies/TRI1913/
ASregistry@tri-kobe.org
Sponsor or person
Institute
Japanese Society of Pediatric Nephrology
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin 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
Kobe University
Address
7-5-1 Kusunokicho Chuouku Kobe
Tel
0783826090
rinri@med.kobe-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
| 2021 | Year | 07 | 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
| 2021 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 05 | Month | 24 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050538
