UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005359 |
|---|---|
| Receipt number | R000006361 |
| Scientific Title | Effects of combination therapy with efonidipine or cilnidipine added on ARB on renal outcomes in hypertensive patients with CKD and proteinuria |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2011/04/01 08:52:47 |
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Basic information
Public title
Effects of combination therapy with efonidipine or cilnidipine added on ARB on renal outcomes in hypertensive patients with CKD and proteinuria
Acronym
Study of renoprotection witH angiotensIN receptor blocker And efonidipine in hyperteNsive patients with chrOnic kidney disease
Scientific Title
Effects of combination therapy with efonidipine or cilnidipine added on ARB on renal outcomes in hypertensive patients with CKD and proteinuria
Scientific Title:Acronym
Study of renoprotection witH angiotensIN receptor blocker And efonidipine in hyperteNsive patients with chrOnic kidney disease
Region
| Japan |
Condition
Condition
Hypertension with chronic kidney disease
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the renoprotective effect (antiproteinuric and prevention of eGFR reduction) of combination therapy of an angiotensin II receptor blocker (ARB) with efonidipine (T/L-type Ca channel blocker).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
(1) Change in aldosterone
(2) Change in proteinuria
(3) Change in eGFR
Key secondary outcomes
Change before and after treatment of the following items:
(1) BNP and hs-CRP
(2) Urinary 8-OHdG
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Irbesartan 200 mg/day and efonidipine 40-60 mg/day (initial dose is 20 mg for elderly patients)
Interventions/Control_2
Irbesartan 200 mg/day and cilnidipine 5-10 mg/day
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Outpatients and in-patients who give written informed consent.
(2) Patients with hypertension and CKD whose blood pressure cannot achieve less than 130/80 mmHg. Patients with persistent proteinuria (>1 g/day) whose blood pressure cannot achieve less than 125/75 mmHg.
(3) Patients with diabetes mellitus whose albuminuria cannot achieve less than 30 mg/g. Patients without diabetes mellitus whose proteinuria cannot achieve less than 300 mg/g.
(4) Patients under treatment with an ARB except irbesartan and Patients who do not achieve the above-mentioned criteria (2) or (3).
(5) Patients with serum Cr≤3.0 mg/dL (patients with eGFR≥40)
Key exclusion criteria
(1) Patients who are younger than 20 or older than 80 years.
(2) Patients who have renovascular hypertension, primary aldosteronism, Cushing's disease, or pheochromocytoma
(3) Patients who had transient ischemic attack or apoplexy within six months prior to enrollment
(4) Patients who had unstable angina, acute myocardial infarction, or underwent coronary artery bypass graft or percutaneous coronary intervention within six months prior to enrollment.
(5) Patients who have congestive heart failure of NYHA class II or higher
(6) Patients who have dissection of aorta or occlusive arterial disease
(7) Patients who have HbA1c > 9.0% or uncontrolled diabetes mellitus
(8) Patients who are pregnant or have possibility of pregnancy
(9) Patients whose levels of AST or ALT are more than 2 times higher than upper normal limits
(10) Patients who had nephrotic syndrome within one year prior to enrollment or have nephrotic syndrome
(11) Patients who have malignant diseases or collagen diseases
(12) Patients in whom irbesartan is contraindicated
(13) Patients in whom efonidipine is contraindicated
(14) Patients in whom cilnidipine is contraindicated
(15) Patients who have previous history of allergy to an ARB or CCB
(16) Patients who are taking another hypertensive drug together with an ARB at maximum dosing
(17) Patients who were deemed not appropriate to participate in this study by doctor
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Higuchi |
Organization
Shinshu University Hospital
Division name
Blood Purification Unit and Nephrology
Zip code
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2823
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Higuchi |
Organization
Shinshu University Hospital
Division name
Blood Purification Unit and Nephrology
Zip code
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2823
Homepage URL
mhiguchi@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Blood Purification Unit and Nephrology, Shinshu University Hospital
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
信州大学医学部附属病院/Shinshu University Hospital
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 01 | Day |
Last modified on
| 2011 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006361
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