UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001247 |
|---|---|
| Receipt number | 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 14:19:14 |
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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
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
syasuno@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
The University of Tokyo Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001499
