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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005759
Receipt No. R000006794
Scientific Title The protective effect for renal function of Aliskiren in hypertensive CKD patients with proteinuria
Date of disclosure of the study information 2011/06/14
Last modified on 2013/06/18

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Basic information
Public title The protective effect for renal function of Aliskiren in hypertensive CKD patients with proteinuria
Acronym The protective effect of Aliskiren for CKD patients with hypertension
Scientific Title The protective effect for renal function of Aliskiren in hypertensive CKD patients with proteinuria
Scientific Title:Acronym The protective effect of Aliskiren for CKD patients with hypertension
Region
Japan

Condition
Condition hypertensive patients with chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to elucidate the efficacy of Aliskiren for reduction of proteinuria in CKD patients who are treated with 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 Plasma aldosterone
Urinary sodium
Blood pressure
Estimation glomerulus filtration (eGFR)
Serum potassium, serum creatinine
Plasma renin activity
Serum thrombomodulin
Serum cystatin C
Fibrinolysis system marker (plasma PAI-I)
Oxidative stress marker (urinary 8-OHDG)
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 Aliskiren add on ARB
Duration of study: 2011.9.1 to 2012.12.31
Duration of registration: 6 months
Obsevation period: 24 weeks after the administration
Interventions/Control_2 Group 2: increase the dose of ARB
Duration of study: 2011.9.1 to 2012.12.31
Duration of registration: 6 months
Obsevation period: 24 weeks after the administration
Interventions/Control_3 Group 3: administer the Ca-blocker add on ARB
Duration of study: 2011.9.1 to 2012.12.31
Duration of registration: 6 months
Obsevation period: 24 weeks after the administration
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. Severe diabetic patients whose HbA1c is over 8.5%
3. In case of severe hepatic injuries
4. nephrotic syndrome
5. the patients with pregnant or possibly pregnant
6. in case with contraindication of Aliskiren
Target sample size 153

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Suzuki
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 Hitoshi Suzuki
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 順天堂大学付属順天堂医院(東京都)、江東高齢者医療センター(東京都)、順天堂大学付属練馬病院(東京都)、順天堂大学付属浦安病院(千葉県)、順天堂大学付属静岡病院(静岡県)、順天堂大学付属越谷病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 14 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 05 Month 16 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 06 Month 12 Day
Last modified on
2013 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006794

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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