UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005441 |
|---|---|
| Receipt number | R000006458 |
| Scientific Title | Renoprotective Effect of ALiskiren in Japanese Hypertensive Patients |
| Date of disclosure of the study information | 2011/04/15 |
| Last modified on | 2015/04/15 15:14:38 |
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Basic information
Public title
Renoprotective Effect of ALiskiren in Japanese Hypertensive Patients
Acronym
Kanazawa REAL trial
Scientific Title
Renoprotective Effect of ALiskiren in Japanese Hypertensive Patients
Scientific Title:Acronym
Kanazawa REAL trial
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the effects of blood pressure and albuminuria and safety on combination therapy of angiotensin II receptor blocker (ARB) and direct renin inhibitor Aliskiren compared with monotherapy of a high dose of ARB in hypertensive patients uncontrolled by a standard dose of ARB.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Change in blood pressure
(2) Change in albuminuria
Key secondary outcomes
Change before and after treatment of the following items:
(1) PRA, PAC, serum creatinine, potassium
(2) Change in eGFR
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A standard dose ARB+Aliskiren 150mg/day
Interventions/Control_2
A high dose ABR monotherapy
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Hypertensive patients who are older than 30 years.
(2) Hypertensive patients whose blood pressure cannot achieve less than 140/90 mmHg under treatment with a standard dose of ARB over 4 weeks.
(3) Outpatients who give written informed consent.
Key exclusion criteria
(1) Patients who have secondary hypertension
(2) Patients with serum Cr =>2.0 mg/dL
(3) Patients who have previous history of allergy to Aliskiren
(4) Patients who are pregnant or have possibility of pregnancy and are lactation period
(5) Patients who have ciclosporin or itraconazole
(6) Patients who have bilateral or unilateral renal artery stenosis
(7) Patients who have hyperkalemia
(8) Patients who have nephrotic syndrome
(9) Patients who were deemed not appropriate to participate in this study by doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Donima |
Organization
Clinic Doniwa
Division name
Internal medicine
Zip code
Address
1-12-5, Hirooka, Kanazawa, Ishikawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Takakuwa |
Organization
Kanazawa Municipal Hospital
Division name
Department of Internal Medicine
Zip code
Address
3-7-3, Heiwa-machi, Kanazawa, Ishikawa
TEL
Homepage URL
Sponsor or person
Institute
Kanazawa Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
金沢市立病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 15 | 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
| 2010 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 14 | Day |
Last modified on
| 2015 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006458
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
