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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044307
Receipt No. R000050538
Scientific Title Japanese Alport Syndrome Patients Registry
Date of disclosure of the study information 2021/07/01
Last modified on 2021/05/24

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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 "See Table 2 Alport Syndrome Diagnostic Criteria (revised in February 2015)"
2) Patients with persistent hematuria whose relatives have already been diagnosed with Alport syndrome by genetic or histopathological examination
3) In the case of the person or a minor in writing Patients who have consented to participate in the study from their substitutes
Key exclusion criteria 1) 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.
2) 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
Email nozu@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Naoki
Middle name
Last name Orita
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
Email ASregistry@tri-kobe.org

Sponsor
Institute Japanese Society of Pediatric Nephrology
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 05 Month 12 Day
Date of IRB
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
2021 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050538

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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