UMIN-CTR Clinical Trial

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
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