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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000497
Receipt No. 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

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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
Email

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
Email katsua-tky@umin.ac.jp

Sponsor
Institute 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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000599

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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