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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004300
Receipt No. R000005140
Scientific Title Anti-Hypertensive treatment of Nephrosclerosis in Elderly
Date of disclosure of the study information 2010/10/01
Last modified on 2016/10/04

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Basic information
Public title Anti-Hypertensive treatment of Nephrosclerosis in Elderly
Acronym Anti-Hypertensive treatment of Nephrosclerosis in Elderly
Scientific Title Anti-Hypertensive treatment of Nephrosclerosis in Elderly
Scientific Title:Acronym Anti-Hypertensive treatment of Nephrosclerosis in Elderly
Region
Japan

Condition
Condition Nephrosclerosis
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare reno-protective effects of olmesaltan with or without azelnidipine in nephroscrelosis patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Change of estimated GFR before and after the treatment
Key secondary outcomes Change of following paparemters before and after the treatment
(1) 1/serum creatinine concetration
(2) Office blood pressure
(3) heart rate
(4) urinary albumin excretion
(5) serum concentrations of BUN, cystatin C, and hs-CRP.

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 YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After observation period for 4 weeks with 20mg of olmesartan, participants were randomly assigned to a group treated with 40mg of olmesartan for 52 weeks.
Interventions/Control_2 After observation period for 4 weeks with 20mg of olmesartan, participants were randomly assigned to a group treated with 20mg of olmesartan plus 16mg of azelnidipine for 52 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
65 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria (1) Participants who gave written informed consent.
(2) Outpatients
(3)Systolic blood pressure at clinic is more than 140 mmHg or diastolic pressure is more than 90 mmHg
(4)Serum HbA1c concentration is less than 6.0
(5)urinary albumin excretion is less than 1g/g.Cr.
(6)Patients treated with RAS-inhibitor but not with Ca channel blocker for 2 months just before initiation of the study.
Key exclusion criteria 1. Hypertensive crisis
2. Hyperkalemia (serum potassium conc.>5.5mM)
3. renal failure (eGFR<30ml/min/1.73m2)
4. bilateral renal artery stenosis
5. newly onset of stroke (within 6 months just before entry)
6. severe congestive heart failure (more than NYHA class III)
7. liver dysfunction (AST/ALT concentration is 5 fold higher than normal range)
8. newly onset of acute myocardial infarction.
9. Malignancy
10. Patients who had severe adverse reactions by Ca channel blockers of RAS inhibitors.
11. Patients who are prescribed immunosuppressant or glucocorticoids.
12. Patients who are prescribed NSAIDs for long time (more than 2 weeks).
13. Patients whose doctors determined as inadequate for the study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunihiro Yamagata
Organization University of Tsukuba
Division name Nephrology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-3202
Email k-yamaga@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chie Saito
Organization University of Tsukuba
Division name Nephrology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-3202
Homepage URL
Email chie.saito@md.tsukuba.ac.jp

Sponsor
Institute Department of Nephrology, University of Tsukuba.
Institute
Department

Funding Source
Organization Department of Nephrology, University of Tsukuba.
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 1. いなしきクリニック(茨城県)
2. 医療法人 桜雄会 塚田整形外科(茨城県)
3. 医療法人社団 光栄会 田谷医院(茨城県)        
4. 医療法人 慈厚会 野上病院(茨城県)
5. 医療法人 道淑会 高野医院(茨城県)
6. 医療法人社団 厚真会 ごとう内科(茨城県)
7. 医療法人社団 桜井内科医院(茨城県)
8. 医療法人社団 三輪会 山手医院(茨城県)
9. かしむら内科消化器科クリニック(茨城県)
10. 医療法人新岳会 研究学園クリニック(茨城県)
11. なかの循環器クリニック(茨城県)
12. なるしま内科医院(茨城県)
13. 南大通りクリニック (茨城県)
14. 宮﨑クリニック(茨城県)
15. やまぐち医院(茨城県)
16. いとう内科胃腸科医院(茨城県)
17. 中島医科歯科クリニック(茨城県)
18. 医療法人社団 しば医院(茨城県)
19. 海老原医院(茨城県)
20. 桜橋クリニック(茨城県)
21. 筑波大学附属病院(茨城県)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 01 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 Open public recruiting
Date of protocol fixation
2010 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 01 Month 31 Day
Date trial data considered complete
2014 Year 01 Month 31 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 09 Month 30 Day
Last modified on
2016 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005140

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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