UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018079 |
|---|---|
| Receipt number | R000020882 |
| Scientific Title | Prevalence of anti-thrombospondin type-1 domain-containing 7A antibodies in Japanese patients with membranous nephropathy |
| Date of disclosure of the study information | 2015/06/25 |
| Last modified on | 2023/07/05 11:17:24 |
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Basic information
Public title
Prevalence of anti-thrombospondin type-1 domain-containing 7A antibodies in Japanese patients with membranous nephropathy
Acronym
Prevalence of anti-thrombospondin type-1 domain-containing 7A antibodies-related membranous nephropathy
Scientific Title
Prevalence of anti-thrombospondin type-1 domain-containing 7A antibodies in Japanese patients with membranous nephropathy
Scientific Title:Acronym
Prevalence of anti-thrombospondin type-1 domain-containing 7A antibodies-related membranous nephropathy
Region
| Japan |
Condition
Condition
Membranous nephropathy
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the prevalence of thrombospondin type-1 domain-containing 7A-related membranous nephropathy in Japanese patients.
Basic objectives2
Others
Basic objectives -Others
To examine the prevalence of enhanced granular expression of thrombospondin type-1 domain-containing 7A and phospholipase A2 receptor in glomeruli of Japanese patients with idiopathic MN by immunohistochemistry.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalence of enhanced granular expression of thrombospondin type-1 domain-containing7A and phospholipase A2 receptor in glomeruli of Japanese patients with idiopathic membranous nephropathy.
Key secondary outcomes
Clinical characteristics of patients with enhanced granular expression of thrombospondin type-1 domain-containing7A and phospholipase A2 receptor in glomeruli.
The prevalence of enhanced granular expression of IgG4 in glomeruli of Japanese patients with idiopathic membranous nephropathy.
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 with the histologic diagnosis of MN established in our institution from 1980 to the present date
Key exclusion criteria
Patients without clinical information or renal specimen
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Iwakura |
Organization
Hamamatsu University School of Medicine
Division name
First department of Medicine
Zip code
4313192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2261
tkms0421@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Iwakura |
Organization
Hamamatsu University School of Medicine
Division name
Internal Medicine I
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2261
Homepage URL
tkms0421@hama-med.ac.jp
Sponsor or person
Institute
Internal Medicine I, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Internal Medicine I, Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Division of Pathology, Hamamatsu University School of Medicine
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine, First Department of Medicine
Address
1-20-1 Handayama, Higashi-ku
Tel
+81-534352261
tkms0421@hama-med.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/26393352/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/26393352/
Number of participants that the trial has enrolled
92
Results
Enhanced granular expression of THSD7A and PLA2R was detected in 9.1% and 52.7%, respectively, of the patients with idiopathic MN. Although none of patients with secondary MN displayed enhanced granular expression of THSD7A, 5.4% of them had enhanced granular expression of PLA2R.
Results date posted
| 2023 | Year | 07 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study included 92 consecutive adult (age > 18 years) patients (48 men and 44 women)
with the histologic diagnosis of MN established in our institution from 1995 to June of 2015.
Participant flow
The requirement for obtaining informed consent was waived by the research ethics committee based on the retrospective design of this study. Instead, a detailed disclosure of this study contents was published on the website of the research ethics committee.
Adverse events
none
Outcome measures
Prevalence of PLA2R, THSD7A, or IgG4+renal specimen.
Clinical information including proteinuria, serum creatinine, serum albumin and so on.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will examine paraffin-embedded tissue sections from patients with biopsy-proven membranous nephropathy and collect the clinical information and laboratory data at the time of biopsy by reviewing the patient's medical records. All patients undergo rigorous screening for secondary causes of membranous nephropathy, which includes serological analysis, physical examination, obtaining information on prescribed medications, and testing for malignancies. membranous nephropathy subjects with diseases associated with secondary membranous nephropathy are classified as having secondary membranous nephropathy. All other patients are classified as having idiopathic membranous nephropathy.
Management information
Registered date
| 2015 | Year | 06 | Month | 25 | Day |
Last modified on
| 2023 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020882
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