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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002049
Receipt No. R000002237
Scientific Title Effects of angiotensin receptor blocker, Candesartan on renal function in type 2 diabetes with chronic kidney disease and hypertension
Date of disclosure of the study information 2009/06/05
Last modified on 2009/12/10

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Basic information
Public title Effects of angiotensin receptor blocker, Candesartan on renal function in type 2 diabetes with chronic kidney disease and hypertension
Acronym J-CARE
Scientific Title Effects of angiotensin receptor blocker, Candesartan on renal function in type 2 diabetes with chronic kidney disease and hypertension
Scientific Title:Acronym J-CARE
Region
Japan

Condition
Condition type 2 diabetes with chronic renal disease and hypertention
Classification by specialty
Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In the 51st annual meeting of Japanese Diabetes Society, it was reported as observational study that Candesartan significantly improved eGFR of diabetes patients with CKD and hypertension. So we are planing to prove these effects of Candesartan in randamized and prospective study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes eGFR 1 year after intervention
Key secondary outcomes IMT, blood pressure (ratio of achievement in BP 130/80mmHg) urinary secretion of albumin, 1 year after intervention

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 not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients: Type 2 diabetes with hypertention (SBP>=130 or DBP>=80) and CKD (eGFR:30<, 60>= mL/min/1.73m2)under regular dose of ARB therapy
Intervention: prospectively and randomly divided into two groups matched for age, gender, BMI, BP, and eGFR. Patients of Candesartan group received Candesartan 12mg/day instead of regular dose of ARB. Those of CCB group received regular dose of CCB or maximum dose of CCB when the patients have already received regular dose of CCB.
If BP is high after intervention, any hypertensive drugs without ARB, CCB, ACEi can be used.
Interventions/Control_2
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
40 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Hypertensive type 2 diabates who were diagnosed by criteria of Japan Diabetes Society.
SBP =>130mmHg or DBP=>80mmHg
eGFR <60ml/min/1.73m2
=>40y.o. <80y.o.
under treatment of small or regular dose of ARB
Key exclusion criteria the patients who are not satisfied with key inclusion criteria.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahisa Hirose
Organization Juntendo University School of Medicine
Division name Metabolism and Endocrinology, Department of Medicine
Zip code
Address 2-1-1 Hongo Bunkyo-ku Tokyo 113-8421 Japan
TEL 03-5802-1579
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Abe
Organization Juntendo University School of Medicine
Division name Metabolism and Endocrinology, Department of Medicine
Zip code
Address 2-1-1 Hongo Bunkyo-ku Tokyo 113-8421 Japan
TEL 03-5802-1579
Homepage URL
Email hirosemd@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Takeda pharmaceutical
Organization
Division
Category of Funding Organization Profit organization
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
2009 Year 06 Month 05 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 Terminated
Date of protocol fixation
2008 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2010 Year 08 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
2009 Year 06 Month 05 Day
Last modified on
2009 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002237

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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