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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005359
Receipt No. 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

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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&#8804;3.0 mg/dL (patients with eGFR&#8805;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
Email

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
Email mhiguchi@shinshu-u.ac.jp

Sponsor
Institute Shinshu University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006361

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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