UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002546 |
|---|---|
| Receipt number | 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 10:03:00 |
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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
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
tamukou@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003112
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