UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017048 |
|---|---|
| Receipt number | R000019774 |
| Scientific Title | Analysis of association between disease of the oral cavity and IgA nephropathy |
| Date of disclosure of the study information | 2015/04/06 |
| Last modified on | 2022/10/10 11:04:58 |
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Basic information
Public title
Analysis of association between disease of the oral cavity and IgA nephropathy
Acronym
Analysis of association between disease of the oral cavity and IgA nephropathy
Scientific Title
Analysis of association between disease of the oral cavity and IgA nephropathy
Scientific Title:Acronym
Analysis of association between disease of the oral cavity and IgA nephropathy
Region
| Japan |
Condition
Condition
IgA nephropathy
Classification by specialty
| Medicine in general | Nephrology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our aim is to investigate whether disease of the oral cavity associate with IgA nephropathy.
Basic objectives2
Others
Basic objectives -Others
Disease activity of IgA nephropathy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
We check disease of the oral cavity and renal function regularly,
We check association between disease of the oral cavity and eGFR, urinary protein, hematuria, dialysis and death after 5years.
Key secondary outcomes
1.Cnm positive Streptococcus in saliva is a risk factor of IgA nephropathy.
2.Degree of dental caries is associated with degree of IgA nephropathy.
3.Degree of periodontal disease is associated with degree of IgA 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have been diagnosed with IgA nephropathy by renal biopsy.
Patients who agree to participate in the study.
Key exclusion criteria
Patients who are taking steroid therapy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Misaki |
Organization
Seirei Hamamatsu General Hospital
Division name
Division of Nephrology
Zip code
830-8558
Address
2-12-12 Sumiyoshi, naka-ku, Hamamatsu, Shizuoka, 430-8558 Japan
TEL
053-474-2222
misakitar@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Misaki |
Organization
Seirei Hamamatsu General Hospital
Division name
Division of Nephrology
Zip code
430-8558
Address
2-12-12 Sumiyoshi, naka-ku, Hamamatsu, Shizuoka, 430-8558 Japan
TEL
053-474-2222
Homepage URL
misakitar@sis.seirei.or.jp
Sponsor or person
Institute
Division of Nephrology, Seirei Hamamatsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Seirei Hamamatsu General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Pediatric Dentistry, Graduate School of Dentistry, Osaka University
Name of secondary funder(s)
Department of Pediatric Dentistry, Graduate School of Dentistry, Osaka University
IRB Contact (For public release)
Organization
Division of Nephrology, Seirei Hamamatsu General Hospital
Address
2-12-12 nakaku sumiyoshi hamamatsu, Japan
Tel
053-474-2222
misakitar@sis.seirei.or.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
聖隷浜松病院腎臓内科
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 06 | 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
120
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The paper is being submitted.
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
Main results already published
Date of protocol fixation
| 2015 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 06 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 06 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 06 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 06 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2015 | Year | 04 | Month | 05 | Day |
Last modified on
| 2022 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019774
