UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058612 |
|---|---|
| Receipt number | R000066999 |
| Scientific Title | Qualitative Interview Study with Physicians Involved in Diagnosis and Management of IgA Nephropathy |
| Date of disclosure of the study information | 2025/07/28 |
| Last modified on | 2025/07/28 08:46:12 |
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Basic information
Public title
Qualitative Interview Study with Physicians Involved in Diagnosis and Management of IgA Nephropathy
Acronym
Qualitative Interview Study with Physicians Involved in Diagnosis and Management of IgA Nephropathy
Scientific Title
Qualitative Interview Study with Physicians Involved in Diagnosis and Management of IgA Nephropathy
Scientific Title:Acronym
Qualitative Interview Study with Physicians Involved in Diagnosis and Management of IgA Nephropathy
Region
| Japan |
Condition
Condition
IgA nephropathy
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
| Clinical immunology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Interviews will be conducted with nephrologists and internists working in hospitals with 200 or more beds, excluding university hospitals and clinics that diagnose and treat patients with IgA nephropathy, and urologists working in university hospitals and hospitals with 200 beds or more to understand the actual medical conditions of patients with IgA nephropathy and the issues they face in their daily practice.
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
<Study items by screener questionnaire>
Doctor's Background (Gender, Age, Year of Graduation)
The prefecture of the medical institution where they work
Number of years of experience in the current department
Years of experience in treating patients with IgA nephropathy
Whether or not the doctor is qualified as a designated physician for intractable diseases
Specialist qualifications
Average number of outpatients per day
Number of patients with IgA nephropathy currently being treated
Number of patients with IgA nephropathy treated so far
Information sources for the treatment of IgA nephropathy
<Interview Study Items>
1. Actual Diagnosis
2. Actual Conditions of Treatment
3. status of regional medical cooperation
4. Communication with Patients
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Physicians who meet the following criteria will be interviewed.
1.Nephrologists,internists
(general/cardiovascular/renal/ hypertension/rheumatism/collagen disease), urologists who treat patients with IgA nephropathy
2. A physician who has treated 3 or more patients with primary IgA nephropathy (excluding dialysis patients) aged 18 years or older in the last 6 months
Key exclusion criteria
Physicians who meet the following criteria are excluded from the interview.
1.Nephrologists and internists working at university hospitals, clinics, and hospitals with fewer than 200 beds
2.Urologists working in clinics and hospitals with fewer than 200 beds
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Goi |
Organization
Viatris Pharmaceuticals Japan G.K.
Division name
Medical Affairs
Zip code
106-0041
Address
1-3-1, Azabudai, Minato-ku, Tokyo, Japan
TEL
03-5656-0400
Nobuhiro.Goi@viatris.com
Public contact
Name of contact person
| 1st name | Anri |
| Middle name | |
| Last name | Watanabe |
Organization
3H Medi Solution Inc.
Division name
IS Promotion Office
Zip code
171-0022
Address
JRE Minami-Ikebukuro Bleg.2F, 1-13-23 Minami-Ikebukuro, Toshima-ku, Tokyo, Japan
TEL
03-5953-2108
Homepage URL
research_info_or2@3h-ms.co.jp
Sponsor or person
Institute
Viatris Pharmaceuticals Japan G.K.
Institute
Department
Personal name
Funding Source
Organization
Viatris Pharmaceuticals Japan G.K.
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
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1 1 3,Kichijoji kitamachi,Musashino shi ,Tokyo,Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.com
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
| 2025 | Year | 07 | Month | 28 | 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
| 2025 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Web Questionnaire Study
Management information
Registered date
| 2025 | Year | 07 | Month | 28 | Day |
Last modified on
| 2025 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066999
