UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060935 |
|---|---|
| Receipt number | R000069733 |
| Scientific Title | Investigation of Humoral Factors in the Pathogenesis of Acquired Kidney Diseases |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/14 12:22:00 |
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Basic information
Public title
Investigation of Humoral Factors in the Pathogenesis of Acquired Kidney Diseases
Acronym
Investigation of Humoral Factors in the Pathogenesis of Acquired Kidney Diseases
Scientific Title
Investigation of Humoral Factors in the Pathogenesis of Acquired Kidney Diseases
Scientific Title:Acronym
HFAK Study
Region
| Japan |
Condition
Condition
Idiopathic nephrotic syndrome, IgA nephropathy, membranous nephropathy, focal segmental glomerulosclerosis, lupus nephritis
Classification by specialty
| Nephrology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using serum from patients with idiopathic nephrotic syndrome and other acquired kidney diseases, we will measure anti-Crb2, anti-nephrin, and anti-sialic acid antibodies as well as related chemokine levels, and evaluate whether these humoral factors can serve as blood biomarkers for disease diagnosis and assessment of disease activity.
Basic objectives2
Others
Basic objectives -Others
Association analysis between humoral factors and kidney disease pathophysiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum anti-Crb2 antibody titers in patients with idiopathic nephrotic syndrome at onset and relapse
Key secondary outcomes
1. Correlation between anti-Crb2 antibody titers and proteinuria
2. Association between anti-Crb2 antibody titers and disease activity
3. Association between serum anti-nephrin antibody titers, serum anti-sialic acid antibody titers, circulating chemokine levels, and serum anti-Crb2 antibody titers
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
The study will include patients diagnosed with idiopathic nephrotic syndrome or other acquired kidney diseases who have stored serum samples, as well as patients or healthy volunteers who provide written informed consent to participate in the prospective cohort study.
Key exclusion criteria
Participants who do not provide consent for participation in the study, or who have evidence of infection such as fever, will be excluded.
Target sample size
1083
Research contact person
Name of lead principal investigator
| 1st name | Kunimasa |
| Middle name | |
| Last name | Yan |
Organization
Kyorin University Suginami Hospital
Division name
Department of Pediatrics
Zip code
166-0012
Address
2-25-1 Wada, Suginami-ku, Tokyo, Japan
TEL
03-3383-1281
yan-kunimasa@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Zentaro |
| Middle name | |
| Last name | Kiuchi |
Organization
Kyorin University School of Medicine
Division name
Department of Pediatrics
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka, Tokyo, Japan
TEL
0422-47-5511
Homepage URL
zenkiuchi@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Denka Company Limited
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
Ethics Committee of Kyorin University School of Medicine
Address
6-20-2 Shinkawa, Mitaka, Tokyo, Japan
Tel
0422-47-5511
rec@ks.kyorin-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
代表施設：杏林大学医学部小児科学教室
分担施設：宮城県立こども病院（宮城県）、埼玉県立小児医療センター（埼玉県）、自治医科大学（栃木県）、埼玉医科大学（埼玉県）、松戸市立総合医療センター（千葉県）、国立病院機構千葉東病院（千葉県）、千葉県こども病院（千葉県）、東京都立小児総合医療センター（東京都）、東京女子医科大学（東京都）、東邦大学大森腎センター（東京都）、東京大学（東京都）、順天堂大学医学部付属練馬病院（東京都）、横浜市立大学附属市民総合医療センター（神奈川県）、北里大学（神奈川県）、静岡県立こども病院（静岡県）、あいち小児保健医療総合センター（愛知県）、藤田医科大学（愛知県）、大阪市立総合医療センター（大阪府）、大阪母子医療センター（大阪府）、大阪医科薬科大学（大阪府）、関西医科大学（大阪府）、岡山大学（岡山県）、倉敷中央病院（岡山県）、福岡市立こども病院（福岡県）、久留米大学（福岡県）、熊本大学（熊本県）、金沢大学（石川県）、金沢医科大学（石川県）、福井大学（福井県）、群馬大学（群馬県）、埼玉医科大学（埼玉県）、千葉大学（千葉県）、東邦大学大森腎センター（東京都）、順天堂大学（東京都）、順天堂大学浦安病院（千葉県）、順天堂大学練馬病院（東京都）、聖路加国際病院（東京都）、虎ノ門病院（東京都）、虎ノ門病院分院（神奈川県）、慶應義塾大学（東京都）、慈恵医科大学（東京都）、東京女子医科大学（東京都）、三重大学（三重県）、京都大学（京都府）、熊本大学（熊本県）、東京都立病院機構研究推進センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 12 | Month | 31 | Day |
Other
Other related information
Using serum from patients with idiopathic nephrotic syndrome and other acquired kidney diseases, we will measure anti-Crb2 antibodies, anti-nephrin antibodies, anti-sialic acid antibodies, and related chemokine levels, and examine whether these humoral factors are associated with disease diagnosis and disease activity.
Management information
Registered date
| 2026 | Year | 03 | Month | 14 | Day |
Last modified on
| 2026 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069733
