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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002546
Receipt No. R000003112
Scientific Title Therapeutic effects of direct renin inhibitor aliskiren added to AT1 receptor blocker in hypertensive patients with chronic kidney disease.
Date of disclosure of the study information 2009/09/25
Last modified on 2015/09/19

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Basic information
Public title Therapeutic effects of direct renin inhibitor aliskiren added to AT1 receptor blocker in hypertensive patients with chronic kidney disease.
Acronym Therapeutic effects of direct renin inhibitor aliskiren added to AT1 receptor blocker in hypertensive patients with chronic kidney disease.
Scientific Title Therapeutic effects of direct renin inhibitor aliskiren added to AT1 receptor blocker in hypertensive patients with chronic kidney disease.
Scientific Title:Acronym Therapeutic effects of direct renin inhibitor aliskiren added to AT1 receptor blocker in hypertensive patients with chronic kidney disease.
Region
Japan

Condition
Condition Hypertension
Chronic kidney disease
Classification by specialty
Medicine in general Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study compares effects of direct renin inhibitor aliskiren and ACE inhibitor benazepril on blood pressure lowering, renal protection, and safety aspects in hypertensive patients with chronic kidney disease who are already treated with standard dose of AT1 receptor blockers without achievement of target blood pressure levels recommended in the guidelines.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 1. Blood pressure (clinical BP, ABPM)
2. Renal function (s-Cr, eGFR, urinary protein/albumin excretion)
Key secondary outcomes 1. Glucose metabolism (FBS, HbA1C, IRI, HOMA-IR)
2. Lipid metabolism (TCHO, LDLC, HDLC, TG)
3. Sympathetic nerve activity, renin-angiotensin system (PRA, PAC, catecholamine, urinary AGT)
4. Oxidative stress (urinary L-FABP, serum pentosidine)
5. Cardiovascular function (BNP, UCG, PWV, central blood pressure)
6. Adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ACE inhibitor group: Patients are initially given 2.5 mg of benazepril once daily for 24 weeks. The dosse of benazepril can be titrated up to 10 mg daily as needed.
Interventions/Control_2 Direct renin inhibitor group: Patients are initially given 150 mg of aliskiren once daily for 24 weeks. The dosse of aliskiren can be titrated up to 300 mg daily as needed.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Hypertensive patients with chronic kidney disease who are already receiving standard doses of AT1 receptor blocker but without achievement of blood pressure lowering to target blood pressure levels.
Key exclusion criteria 1. Dialysis patients
2. Patients with history of angioedema
3. Patients on apheresis therapy
4. Patients taking cyclosporin
5. History of hypersensitivity to benazepril and/or aliskiren
6. Pregnant women and/or women who are suspect of pregnancy
7. Patients judged as inappropriate for the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouichi TAMURA
Organization Yokohama City University School of Medicine
Division name Department of Cardiorenal Medicine
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL 045-787-2635
Email tamukou@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kouichi TAMURA
Organization Yokohama City University School of Medicine
Division name Department of Cardiorenal Medicine
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL 045-787-2635
Homepage URL
Email tamukou@med.yokohama-cu.ac.jp

Sponsor
Institute Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School 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 横浜市立大学附属病院
Yokohama City University Hospital

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 25 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
2009 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2013 Year 09 Month 01 Day
Date of closure to data entry
2015 Year 08 Month 01 Day
Date trial data considered complete
2016 Year 08 Month 01 Day
Date analysis concluded
2017 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 25 Day
Last modified on
2015 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003112

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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