UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058311 |
|---|---|
| Receipt number | R000066652 |
| Scientific Title | Qualitative Patient Interview Study in Patients with IgA Nephropathy |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/06/30 08:53:20 |
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Basic information
Public title
Qualitative Patient Interview Study in Patients with IgA Nephropathy
Acronym
Qualitative Patient Interview Study in Patients with IgA Nephropathy
Scientific Title
Qualitative Patient Interview Study in Patients with IgA Nephropathy
Scientific Title:Acronym
Qualitative Patient Interview Study in Patients with IgA Nephropathy
Region
| Japan |
Condition
Condition
IgA nephropathy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the actual situation of patients with IgA nephropathy, we will conduct an interview survey study of patients with IgA nephropathy with the aim of creating a patient journey map by digging deeper into the details of the common issues obtained in the previous quantitative survey ("Questionnaire Survey for Japanese IgA nephropathy patients").
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 based on interviews
consultation - definitive diagnosis
Symptoms (presence or absence of fatigue, edema, or frequent urination and the occasion for medical examination, Ease of consultation with the attending physician)
Treatment (Impact on Daily Life, Adjustment of the need and timing of hospitalization, Desired treatment options, Burden of medical expenses and public support, Treatment of other diseases and collaboration between departments, Hopes and goals for the future)
obtaining information, communicating with related parties (Relationships with people around you (family, friends, work) and medical professionals, Features of < websites and materials)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet the following criteria will be included in the analysis:
1. Patients with a definitive diagnosis of IgA nephropathy by renal biopsy
2. Patients over 18 years of age and residing in Japan from diagnosis to the present
3. Patients who have no problems conducting interviews in Japanese or reading and writing
4. Patients who have received steroids or immunosuppressive agents or have tonsillectomy
5. Patients who have obtained consent by the person voluntarily
Key exclusion criteria
Patients who meet the following criteria will be excluded from the analysis:
1. Patients with a diagnosis of mental illness (depression, schizophrenia, etc.)
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Hayami |
| Middle name | |
| Last name | Kudo |
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
Hayami.Kudo@viatris.com
Public contact
Name of contact person
| 1st name | Anri |
| Middle name | |
| Last name | Watanabe |
Organization
3H Medi Solution Inc.
Division name
The rare intractable disease information site "RareS." Inquiry Desk
Zip code
171-0022
Address
JRE Minami-Ikebukuro Bleg.2F, 1-13-23 Minami-Ikebukuro, Toshima-ku, Tokyo, Japan
TEL
03-5985-0053
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 | 06 | Month | 30 | 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 | 06 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 23 | 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 | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066652
