UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063160 |
|---|---|
| Receipt number | R000072291 |
| Scientific Title | Physician and Patient Preferences Study in IgA Nephropathy: A Discrete Choice Experiment |
| Date of disclosure of the study information | 2026/10/05 |
| Last modified on | 2026/10/03 15:08:04 |
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Basic information
Public title
Physician and Patient Preferences Study in IgA Nephropathy: A Discrete Choice Experiment
Acronym
Physician and Patient Preferences Study in IgA Nephropathy: A Discrete Choice Experiment
Scientific Title
Physician and Patient Preferences Study in IgA Nephropathy: A Discrete Choice Experiment
Scientific Title:Acronym
Physician and Patient Preferences Study in IgA Nephropathy: A Discrete Choice Experiment
Region
| Japan |
Condition
Condition
IgA nephropathy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantify the preferences of patients with IgA nephropathy and physicians involved in IgA nephropathy care in Japan for multiple treatment attributes and to determine the relative importance of these attributes.
Basic objectives2
Others
Basic objectives -Others
To identify the trade-offs between improvements in convenience associated with treatment changes and other treatment attributes in IgA nephropathy treatment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preferences for and the relative importance of multiple treatment attributes in IgA nephropathy treatment
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients
1. Diagnosis of IgAN confirmed by renal biopsy.
2. An eGFR of >=20 mL/min/1.73 m2 at the most recent renal function assessment.
3. Under medical care or follow-up at the time of the survey and considered eligible for participation by the treating physician.
4. Able to complete the survey independently.
Physicians
1. Board-certified nephrologists.
2. Experience providing pharmacological treatment to patients with IgAN within the past 12 months.
3. Agreement to participate in the survey.
Key exclusion criteria
Patients
1.Patients with secondary IgA nephropathy (IgAN).
2.Patients who are currently receiving dialysis therapy.
3.Patients with a history of kidney transplantation.
Physicians
1.No specific exclusion criteria.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Kondo |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Kondo.Tomohiro.a@otsuka.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Kondo |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Homepage URL
Kondo.Tomohiro.a@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical 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
RIHDS Ethical Review Board
Address
12th Floor, Suitomo Shiba Daimon Building, 2-5-5 Shiba Daimon, Minato-ku, Tokyo, Japan
Tel
03-5733-5010
rihds@jmdc.co.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
| 2026 | Year | 10 | Month | 05 | 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
| 2026 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To quantify the preferences of patients with IgAN and physicians involved in IgAN care in Japan for multiple IgAN treatment attributes and to determine the relative importance of these attributes.
Management information
Registered date
| 2026 | Year | 10 | Month | 03 | Day |
Last modified on
| 2026 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072291
