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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001247
Receipt No. R000001499
Scientific Title Study of Assessment for Kidney function by Urinary microalbumin in RAndomized Trial
Date of disclosure of the study information 2008/07/14
Last modified on 2014/01/07

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Basic information
Public title Study of Assessment for Kidney function by Urinary microalbumin in RAndomized Trial
Acronym SAKURA Trial
Scientific Title Study of Assessment for Kidney function by Urinary microalbumin in RAndomized Trial
Scientific Title:Acronym SAKURA Trial
Region
Japan

Condition
Condition Hypertension with diabetic nephropathy
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the antiproteinuric effect of cilnidipine, a dual L-/N-type calcium channel blocker, and amlodipine, an L-type calcium channel blocker, in hypertensive patients with diabetic nephropathy under treatment with an inhibitor of the renin angiotensin system
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Change in urinary albumin-creatinine ratio (mg/g*Cr)
Key secondary outcomes 1) urinary albumin-creatinine ratio (mg/g*Cr), 2) stage of chronic kidney disease (CKD), 3) serum creatinine level, 4) estimated glomerular filtration rate, 5) cardiovascular event, 6) antihypertensive effect, 7) heart rate, 8) safety parameters

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 amlodipine (initial dose is 5mg/day, but 2.5-10mg is available depending on the effect of blood pressure reduction)
Interventions/Control_2 cilnidipine (initial dose is 10mg/day, but 5-20mg is available depending on the blood pressure level)
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) urinary albumin-creatinine ratio (mg/g*Cr): 30-300mg/g*Cr (casual urine), 2) serum creatinine: 1.5mg/dl and below, 3) blood pressure (BP): systolic BP (SBP) 130mmHg and above or diastolic BP (DBP) 80mmHg and above, and SBP less than 180mmHg and DBP less than 110mmHg, 4) hemoglobin A1c (HbA1c): HbA1c less than 8.0%, 5) age: from 20 to 75 years old, 6) informed consent, 7) patients who received an antidiabetic therapy for 3 months or more, 8) patients who received an antihypertensive treatment with angiotensin II receptor blockers (ARB) or angiotensin converting enzyme (ACE) inhibitors for 3 months or more, and did not receive calcium channel blockers (CCB) during the most recent 3 months before the enrollment
Key exclusion criteria 1) hypertensive emergency, 2) nephropathy due to other than diabetes, 3) history of severe side effects of a CCB, an ARB or an ACE inhibitor, 4) cerebrovascular disease within 6 months of the start of the trial, 5) severe heart failure (New York heart Association classes III and IV), severe arrhythmia, and myocardial infarction within 6 months of the start of the trial, 6) AST and ALT 5 times and more the upper limit of institution's normal, 7) pregnancy, 8) prior use of corticosteroids, immunosuppresants, or nonsteroidal anti-inflammatory drugs (NAISDs), 9) patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiro FUJITA
Organization The University of Tokyo Graduate School of Medicine
Division name Department of Nephrology and Endocrinology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03
Email Toshiro.FUJITA@rcast.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Department of EBM Research
Organization Kyoto university Hospital
Division name iACT
Zip code
Address Syogoinkawaharamachi 54, Sakyo-ku, Kyoto
TEL 0120105894
Homepage URL
Email syasuno@kuhp.kyoto-u.ac.jp

Sponsor
Institute The University of Tokyo Graduate School of Medicine
Institute
Department

Funding Source
Organization Department account fund
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
2008 Year 07 Month 14 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 Completed
Date of protocol fixation
2007 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 07 Month 14 Day
Last modified on
2014 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001499

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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