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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008615
Receipt No. R000010126
Scientific Title A prospective comparison of direct renin inhibitor aliskiren and AT1 receptor blocker in hypertensive patients with chronic kidney disease(CKD).
Date of disclosure of the study information 2012/08/04
Last modified on 2016/02/04

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Basic information
Public title A prospective comparison of direct renin inhibitor aliskiren and AT1 receptor blocker in hypertensive patients with chronic kidney disease(CKD).
Acronym A prospective comparison of direct renin inhibitor aliskiren and AT1 receptor blocker in hypertensive patients with chronic kidney disease(CKD).
Scientific Title A prospective comparison of direct renin inhibitor aliskiren and AT1 receptor blocker in hypertensive patients with chronic kidney disease(CKD).
Scientific Title:Acronym A prospective comparison of direct renin inhibitor aliskiren and AT1 receptor blocker in hypertensive patients with chronic kidney disease(CKD).
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 AT1 receptor blocker (ARB) on blood pressure lowering, renal protection, ROS reduction and safety aspects in hypertensive patients with chronic kidney disease who are already treated with standard dose of ARB.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. BW, obesity, abdominal circumference
2. Clinical blood pressure
3. Home blood pressure
4. ABPM
5. Renal function (urinary protein/albumin/Cr excretion, BUN, eGFR, uric acid, L-FABP)
6. Vascular function(AI, ABI/baPWV), CAVI, FMD)
7. Sympathetic nerve activity
8. Glucose metabolism (FBS, HbA1C, IRI, HOMA-IR)
9. Lipid metabolism (TCHO, LDLC, HDLC, TG)
10.Endocrine (PRA, PAC, urinary aldosteron concentration, BNP)
11.Oxidative stress (h-s CRP, serum pentosidine)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Direct renin inhibitor group: Patients are initially given 150-300 mg of aliskiren once daily for 24 weeks.
Interventions/Control_2 ARB group: Patients are initially given standard dose of ARB once daily for 24 weeks.
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 1. Hypertensive patients with CKD G1-G4.
2. Patients who are already receiving antihypertensive therapy including ARB.
Key exclusion criteria 1. CKD G5, or dialysis patients.
2. History of hypersensitivity to ARB and/or aliskiren.
3. Pregnant women and/or women who are suspect of pregnancy.
4. Patients taking cyclosporin and/or itraconazole.
Patients with history of angioedema
5. 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 Self.
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 08 Month 04 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
2012 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
2015 Year 08 Month 31 Day
Date of closure to data entry
2015 Year 08 Month 31 Day
Date trial data considered complete
Date analysis concluded
2015 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2012 Year 08 Month 04 Day
Last modified on
2016 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010126

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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