UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011825 |
|---|---|
| Receipt number | R000013820 |
| Scientific Title | Study on the clinical significance of Saireito in patients with hypertensive nephropathy |
| Date of disclosure of the study information | 2013/09/20 |
| Last modified on | 2013/09/20 16:50:59 |
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Basic information
Public title
Study on the clinical significance of Saireito in patients with hypertensive nephropathy
Acronym
Clinical effects of Saireito in patients with hypertensive nephropathy
Scientific Title
Study on the clinical significance of Saireito in patients with hypertensive nephropathy
Scientific Title:Acronym
Clinical effects of Saireito in patients with hypertensive nephropathy
Region
| Japan |
Condition
Condition
hypertensive nephropathy
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the change of microalbuminuria and renal dysfunction before and after the administration of Saireito in patients with chronic hypertensive nephropathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decrease in microalbuminuria
Key secondary outcomes
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
| Medicine |
Interventions/Control_1
Saireito (EK-114, Kracie Pharma, Ltd., Tokyo, Japan) at 8.1g was additionally administered for 12 weeks
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with persistent hypertension and with microalbuminuria ranging 20 to 400 mg/gCr
Key exclusion criteria
* in pregnancy and lactating
* contraindicative or impossible to use
for some reason for Saireito
* treated with oral corticosteroids or
immunosuppressant therapy
* interstitial pneumonitis
* definite diabetes mellitus
* marked renal impairment (eGFR = or <
30 ml/min)
* primary renal disease
* secondary renal disease
* serious CHF
* serious arrythmia
* within 6 months after AMI
* within 6 months after cerebrovascular
disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumihiko Hinoshita |
Organization
National Center for Global Health and Medicine Hospital
Division name
Department of Nephrology
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
fhinoshi@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumihiko Hinoshita |
Organization
National Center for Global Health and Medicine Hospital
Division name
Department of Nephrology
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
fhinoshi@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
nothing
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
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
| 2013 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | 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
| 2013 | Year | 09 | Month | 20 | Day |
Last modified on
| 2013 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013820
| 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 |
