UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009157 |
|---|---|
| Receipt number | R000010636 |
| Scientific Title | Chronic epipharyngitis in Glomerulonephritis |
| Date of disclosure of the study information | 2012/10/21 |
| Last modified on | 2015/08/05 22:23:37 |
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Basic information
Public title
Chronic epipharyngitis in Glomerulonephritis
Acronym
Epipharyngitis & GN
Scientific Title
Chronic epipharyngitis in Glomerulonephritis
Scientific Title:Acronym
Epipharyngitis & GN
Region
| Japan |
Condition
Condition
Glomerular disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the Treatment of epipharyngitis with Zinc chloride can improve the complete remission rate in patients with glomerular disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Complete remission (proteinuria <30mg/gCre and urinary RBC 0/HPF)
Key secondary outcomes
1) Duration, in which complete remission is achieved
2) safety of the treatment with Zinc chloride
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Zinc chloride
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) glomerular disease (proteinuria >30mg/gCre and/or urinary RBC >0/HPF)
2) need for epipharyngeal treatment
3) provided informed consent
Key exclusion criteria
1) pregnancy
2) lactation
3) negative opinion judged by attending doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio FUKUDA |
Organization
Nagoya City University Hospital
Division name
Division of Nephrology
Zip code
Address
1 Kawasumi, Nagoya 467-8601, Japan
TEL
81-52-853-8221
m-fukuda@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio FUKUDA |
Organization
Nagoya City University Hospital
Division name
Division of Nephrology
Zip code
Address
m-fukuda@med.nagoya-cu.ac.jp
TEL
81-52-853-8221
Homepage URL
m-fukuda@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate Shool of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate Shool of Medical Sciences
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
Address
Tel
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
名古屋市立大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 21 | 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
Forty patients enrolled.
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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 21 | Day |
Last modified on
| 2015 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010636
| 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 |
