UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007369 |
|---|---|
| Receipt number | R000008535 |
| Scientific Title | The protective effect by the medical timing of Valsartan-160mg in hypertensive CKD patients with proteinuria |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2015/03/25 10:07:49 |
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Basic information
Public title
The protective effect by the medical timing of Valsartan-160mg in hypertensive CKD patients with proteinuria
Acronym
The protective effect by the medical timing of Valsartan-160mg in hypertensive CKD patients with proteinuria
Scientific Title
The protective effect by the medical timing of Valsartan-160mg in hypertensive CKD patients with proteinuria
Scientific Title:Acronym
The protective effect by the medical timing of Valsartan-160mg in hypertensive CKD patients with proteinuria
Region
| Japan |
Condition
Condition
hypertensive patients with chronic kidney disease
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the efficacy of valsartan(160mg) for the reduction of proteinuria and changing the medical timing to examine in CKD patients who are treated by the change from the standard dose of ARB.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Levels of urinary protein after 12 and 24 weeks
Key secondary outcomes
Clinic Blood pressure
Home Blood pressure
Ambulatory Blood pressure
Estimation glomerulus filtration (eGFR)
Serum potassium, serum creatinine
Harmful phenomenon
will be analyzed after 12 and 24 wekks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group 1: administer the change of Valsartan from the standard dose of ARB. (
Take 1 tablet in the morning)
Interventions/Control_2
Group 2: administer the change of Valsartan from the standard dose of ARB. (
Take 1 tablet in the evening)
Interventions/Control_3
Group 3: administer the change of Valsartan from the standard dose of ARB. (
Take 1 tablet in the morning and in the evening)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients with proteinuria (more than 0.3g/g Cr)
2. In cases that systolic BP is over 130mmHg and diastolic BP is over 80mmHg who administer standard dose of ARB.
The standard dose of ARB are as below.
Valsartan 80mg, Losartan 50mg, Candesartan 8mg, Terumisartan 40mg, Olmesartan 20mg
Key exclusion criteria
1. systolic BP is over 180mmHg, or diastolic BP is over 110mmHg
2. In case of severe hepatic injuries
3. nephrotic syndrome
4. the patients with pregnant or possibly pregnant
5. in case with contraindication of valsartan
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Tomino |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Internal Medicine, Division of Nephrology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Asanuma |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Internal Medicine, Division of Nephrology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
Department of Internal Medicine, Division of Nephrology, Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine, Division of Nephrology, Juntendo University Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2012 | Year | 04 | Month | 01 | 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
| 2012 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 23 | Day |
Last modified on
| 2015 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008535
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