UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006495 |
|---|---|
| Receipt number | R000007705 |
| Scientific Title | Relationship between proteinuria, podocyte injury, and N-type calcium channel in podcyte in patients with chronic renal diseases |
| Date of disclosure of the study information | 2011/10/11 |
| Last modified on | 2017/04/10 19:30:58 |
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Basic information
Public title
Relationship between proteinuria, podocyte injury, and N-type calcium channel in podcyte in patients with chronic renal diseases
Acronym
N-type calcium channel in podcyte in patients with chronic renal diseases
Scientific Title
Relationship between proteinuria, podocyte injury, and N-type calcium channel in podcyte in patients with chronic renal diseases
Scientific Title:Acronym
N-type calcium channel in podcyte in patients with chronic renal diseases
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to investigate the relationship between proteinuria, podocyte injury, and N-type calcium channel in podocytein patients with chronic renal disease
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
immunoreactivity for desmin, N-type calcium
channel, Wilms' tumor factor 1, and podocin in renal biopsy specimens
mRNA expression of desmin, N-type calcium channel, podocin,nephrin in renal biopsy specimens
urinary excretion of protein
systemic blood pressure
Key secondary outcomes
blood urea nitrogen, serum creatinine, effective renal plasma flow, creatinine clearance, filtration fraction, urinary excretion of angiotensinogen
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 with chronic renal disease
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Konishi |
Organization
Osaka City General Hospital
Division name
Nephrology and Hypertension
Zip code
Address
2-13-22, Miyakojimahonndouri, Miyakojima-ku, Osaka 534-0021, Japan
TEL
81-6-6929-1221
ymsry-ko@msic.med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Konishi |
Organization
Osaka City General Hospital
Division name
Nephrology and Hypertension
Zip code
Address
2-13-22, Miyakojimahonndouri, Miyakojima-ku, Osaka 534-0021, Japan
TEL
06-6929-1221
Homepage URL
ymsry-ko@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Division of Nephrology and Hypertension, Osaka City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology and Hypertension, Osaka City General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Pharmacology, Faculty of Medicine, Kagawa University
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 11 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2011 | Year | 10 | Month | 06 | Day |
Last modified on
| 2017 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007705
