UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061754 |
|---|---|
| Receipt number | R000070660 |
| Scientific Title | Effects of Epipharyngeal Abrasive Therapy on Serum APRIL Levels and IgA-related Immunological Markers in Patients with IgA Nephropathy: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/31 20:28:55 |
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Basic information
Public title
Effects of Epipharyngeal Abrasive Therapy on Serum APRIL Levels and IgA-related Immunological Markers in Patients with IgA Nephropathy: A Prospective Observational Study
Acronym
EAT-IgAN-APRIL Study
Scientific Title
Effects of Epipharyngeal Abrasive Therapy on Serum APRIL Levels and IgA-related Immunological Markers in Patients with IgA Nephropathy: A Prospective Observational Study
Scientific Title:Acronym
Prospective Study of the Effects of EAT on APRIL and Immunological Markers in IgA Nephropathy
Region
| Japan |
Condition
Condition
IgA nephropathy
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify changes in serum APRIL levels before and after Epipharyngeal Abrasive Therapy (EAT) in patients with IgA nephropathy.
Basic objectives2
Others
Basic objectives -Others
This study aims to explore changes in immunological and clinical markers (BAFF, Gd-IgA1, uromodulin, urinalysis findings, renal function, and endoscopic epipharyngeal findings). It is an exploratory observational study and does not evaluate efficacy or safety.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in serum APRIL levels between baseline (before initiation of EAT) and after 12 EAT sessions
Key secondary outcomes
Change in serum BAFF levels
Change in serum Gd-IgA1 levels
Change in serum uromodulin levels
Change in urinalysis findings (dipstick and RBC/HPF)
Change in serum creatinine and eGFR
Change in endoscopic epipharyngeal findings (reference evaluation)
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older
Diagnosed with chronic epipharyngitis and undergoing EAT as part of routine clinical care
Patients with active IgA nephropathy, remission-phase IgA nephropathy, or non-renal disease controls
Able to undergo blood tests, urinalysis, and endoscopic evaluation at baseline and after 12 EAT sessions
Provided written informed consent for study participation
Key exclusion criteria
Patients with acute inflammatory diseases such as acute epipharyngitis, acute sinusitis, or acute tonsillitis
Patients unable to undergo scheduled blood tests, urinalysis, or endoscopic evaluation
Patients for whom EAT is medically inappropriate (e.g., severe gag reflex, bleeding tendency)
Patients with severe systemic diseases (e.g., heart failure, liver failure, malignancy) that may interfere with study participation
Pregnant women or those with possible pregnancy
Any patient deemed unsuitable for participation by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Mogitate |
Organization
Mogitate ENT Clinic
Division name
Mogitate ENT Clinic
Zip code
2130011
Address
4F-401, Sekiguchi Daiichi Building, 1-2-5 Hisamoto, Takatsu-ku, Kawasaki-shi, Kanagawa, Japan
TEL
0448654187
mogitateentjp@m08.itscom.net
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Mogitate |
Organization
Mogitate Medical Corporation
Division name
Mogitate ENT Clinic
Zip code
2130011
Address
4F-401, Sekiguchi Daiichi Building, 1-2-5 Hisamoto, Takatsu-ku, Kawasaki-shi, Kanagawa, Japan
TEL
0448654187
Homepage URL
mogitateentjp@m08.itscom.net
Sponsor or person
Institute
Mogitate ENT Clinic
Institute
Department
Personal name
Manabu Mogitate
Funding Source
Organization
Mogitate ENT Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board: Ota General Hospital Ethics Committee
Address
1-50 Nisshin-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
Tel
0442440131
info@ota-g-hospital.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
| 2026 | Year | 06 | 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
| 2026 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 05 | Month | 31 | Day |
Last modified on
| 2026 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070660
