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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007369
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Internal Medicine, Division of Nephrology, Juntendo University Faculty of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008535

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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