UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032074 |
|---|---|
| Receipt number | R000035973 |
| Scientific Title | A case-control study on the influence of glycolipid GM3 in glomerular disease |
| Date of disclosure of the study information | 2018/04/10 |
| Last modified on | 2021/10/13 17:09:45 |
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Basic information
Public title
A case-control study on the influence of glycolipid GM3 in glomerular disease
Acronym
GM3 in glomerular disease study
Scientific Title
A case-control study on the influence of glycolipid GM3 in glomerular disease
Scientific Title:Acronym
GM3 in glomerular disease study
Region
| Japan |
Condition
Condition
glomerular disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the association between glycolipid GM3 expression and glomerular disease.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
proteinuria, renal function after 2 years of renal biopsy
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Diseased:
Patients diagnosed with renal biopsyin in Kitasato university hospital, division of nephrology(2010/1/1-2015/12/31)
a) MCNS, b) FSGS, c) IgA-nephritis, d) Membrane nephritis, e) DM-N
2) control
Nephrectomy patients who assent in Kitasato University Hospital, Division of Urology (2018/4/1-2020/12/31). age: 20-75 ages
Key exclusion criteria
Participation refusal from principal or agent
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | SHOKICHI |
| Middle name | |
| Last name | NAITO |
Organization
KITASATO UNIVERSITY HOSPITAL
Division name
DIVISION OF NEPHROLOGY
Zip code
252-0375
Address
1-15-1 Kitasato, Minami, Sagamihara, 252-0374, Japan
TEL
042-778-8111
snaito@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | SHOKICHI |
| Middle name | |
| Last name | NAITO |
Organization
KITASATO UNIVERSITY HOSPITAL
Division name
DIVISION OF NEPHROLOGY
Zip code
252-0375
Address
1-15-1 Kitasato, Minami, Sagamihara, 252-0374, Japan
TEL
042-778-8111
Homepage URL
snaito@med.kitasato-u.ac.jp
Sponsor or person
Institute
KITASATO UNIVERSITY HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
Kitasato University, School Of Medicene
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Medical Ethics Organization (KMEO)
Address
1-15-1 Kitasato, Minami, Sagamihara, 252-0374, Japan
Tel
042-778-8273
rinrib@med.kitasato-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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 10 | 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
228
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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Case-control study
Management information
Registered date
| 2018 | Year | 04 | Month | 03 | Day |
Last modified on
| 2021 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035973
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
