UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000497 |
|---|---|
| Receipt number | R000000599 |
| Scientific Title | Assesment for Response to Candesartan in Diabetic Nephropathy |
| Date of disclosure of the study information | 2006/12/31 |
| Last modified on | 2007/07/26 16:23:16 |
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Basic information
Public title
Assesment for Response to Candesartan in Diabetic Nephropathy
Acronym
ARCADIA
Scientific Title
Assesment for Response to Candesartan in Diabetic Nephropathy
Scientific Title:Acronym
ARCADIA
Region
| Japan |
Condition
Condition
Hypertensive patients with diabetic nephropathy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To evaluate whether angiotensin receptor blocker (ARB) has renoprotective effect in hypertensive patients with nephropathy due to type 2 diabetes.
2. To assess whether ARB exhibits renoprotective effect beyond blood pressure (BP)-lowering action even if BP is strictly controlled.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Urinary albumin, urinary protein
2. Serum creatinin
Key secondary outcomes
Cardiovascular events: cardiovascular death, endstage renal failure, heart failure, stroke, total death
Laboratory data: Oxidative stress markers, chest X ray, electrocardiography, carotid artery echo (intima media thickness: IMT), palse wave verosity (PWV), echocardiography (left ventricular mass index)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
High-dose ARB group: Candesartan 12mg/day
Interventions/Control_2
low-dose ARB group: Candesartan 4mg/day
Interventions/Control_3
Non renin-angiotensin (RA) system inhibiting agents treated group: ARB and angiotensin converting enzyme (ACE) inhibitor are not administered
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. Type 2 diabetes mellitus
2. Diabetic nephropathy: Microalbuminuria (urinary albumin/ creatinin ratio is 30 mg/gCr or above)
3. BP is 130/85 mmHg or above.
4. Serun creatinin is 1.5 mg/dL or below.
Key exclusion criteria
1. Severe hypertension: 180/110 mmHg or above.
2. Severe cardiovascular conplication
3. Severe diabetes
4. Pregnancy
5. History of severe side effect of ARB or ACE inhibitor
6. Patients who are treating with ARB or ACE inhibitor
7. Patients who are inadequate to enty this study by physisicans in charge.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiro Fujita |
Organization
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuyuki Ando |
Organization
University of Tokyo Graduate School of Medicine
Division name
Molecular Cardiovascular Metabolism
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9119
Homepage URL
katsua-tky@umin.ac.jp
Sponsor or person
Institute
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
| 2006 | Year | 12 | Month | 31 | 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
| 2002 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 10 | Month | 03 | Day |
Last modified on
| 2007 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000599
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