UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002049 |
|---|---|
| Receipt number | 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 15:20:17 |
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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
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
hirosemd@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002237
