UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007456 |
|---|---|
| Receipt number | R000008784 |
| Scientific Title | Mechanisms of antiproteinuric effects of azelnidipine in hypertensive patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2012/03/08 |
| Last modified on | 2014/09/07 21:25:21 |
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Basic information
Public title
Mechanisms of antiproteinuric effects of azelnidipine in hypertensive patients with type 2 diabetes mellitus
Acronym
Mechanisms of antiproteinuric effects of AzelnidiPine IN hypertensive patients with type 2 Diabetes Mellitus (MAP in DM)
Scientific Title
Mechanisms of antiproteinuric effects of azelnidipine in hypertensive patients with type 2 diabetes mellitus
Scientific Title:Acronym
Mechanisms of antiproteinuric effects of AzelnidiPine IN hypertensive patients with type 2 Diabetes Mellitus (MAP in DM)
Region
| Japan |
Condition
Condition
Essential hypertension with type 2 diabetes mellitus and proteinuria
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Strict blood pressure (BP) control as well as inhibition of the renin-angiotensin system (RAS) is essential in the management of hypertensive patients with proteinuria. However, effective BP control is particularly difficult to achieve in patients with diabetes mellitus and target BP levels are seldom achieved with a standard dose of RAS inhibitors. Although calcium channel blockers are frequently used in combination with RAS inhibitors, the blockers have diverse characteristics; some calcium channel blockers, which inhibit N-type or T-type calcium channels, show antiproteinuretic effects similar to those of angiotensin converting enzyme inhibitors. Although azelnidipine, a calcium channel blocker, has been reported to produce potent antiproteinuretic effects, mechanisms underlying the beneficial effect are not clear because the compound has neither N-type nor T-type calcium channel blocking properties. Thus, the present study was designed to examine time-dependent changes in urinary excretion of protein, blood pressure, and several markers of kidney function after the start of treatment with azelnidipine in order to investigate the underlying mechanism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Changes in urinary excretion of albumin from baseline to 1, 2, 4, 12 weeks after randomization
(2) Changes in blood pressure and heart rate from baseline to 1, 2, 4, 12 weeks after randomization
(3) Changes in urine L-FABP, OHdG, sodium, and metanephrine from baseline to 1, 2, 4, 12 weeks after the treatment with azelnidipine
(4) Changes in serum creatinine, hs-CRP, IL-6, ADMA, cystatin C, and pentosidine from baseline to 1, 2, 4, 12 weeks after the treatment with azelnidipine
(5) Relationship of (1) with (2) , (3), (4), (5)
Key secondary outcomes
home BP, HbA1c
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
MAP in DM is a 12-week, prospective, randomized, open, blinded-endpoint (PROBE) study. Type 2 diabetic patients with hypertension and proteinuria are recruited and antihypertensive medications are either started on or switched to a standard dose of an angiotensin receptor blocker (run-in-period). After a 3-month run-in period, baseline evaluations are performed and patients with BP =>130/80mmHg and urinary excretion of albumin =>300mg/g creatinine are enrolled. Then, patients are randomly assigned to receive either azelnidipine (16mg/day) or amlodipine (5mg/day) in combination with a standard dose of an angiotensin receptor blocker for additional 12 months. In cases that the target blood pressure level (<130/80mmHg) is not achieved, increasing doses of an alpha-blocker are prescribed to achieve the target level.
Interventions/Control_2
MAP in DM is a 12-week, prospective, randomized, open, blinded-endpoint (PROBE) study. Type 2 diabetic patients with hypertension and proteinuria are recruited and antihypertensive medications are either started on or switched to a standard dose of an angiotensin receptor blocker (run-in-period). After a 3-month run-in period, baseline evaluations are performed and patients with BP =>130/80mmHg and urinary excretion of albumin =>300mg/g creatinine are enrolled. Then, patients are randomly assigned to receive either azelnidipine (16mg/day) or amlodipine (5mg/day) in combination with a standard dose of an angiotensin receptor blocker for additional 12 months. In cases that the target blood pressure level (<130/80mmHg) is not achieved, increasing doses of an alpha-blocker are prescribed to achieve the target level.
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
Type 2 diabetic patients with essential hypertension and proteinuria are recruited and are either started on or switched to a monotherapy with a standard dose of an angiotensin receptor blocker for 3 months (run-in -period). Patients with BP =>130/80 mmHg and urinary excretion of albumin =>300mg/g creatinine at the end of run-in-period are finally enrolled.
Key exclusion criteria
Exclusion criteria are: secondary hypertension; history of acute coronary syndrome, heart failure, coronary revascularization, or stroke within the previous 6 months; uncontrolled diabetes mellitus (HbA1c >9.0%); confirmed or suspected renal artery stenosis; serum creatinine of 1.5mg/dl or more for men and 1.2mg/dl or more for women; contraindication to calcium channel blockers; pregnant women; or clinic systolic blood pressure >180mmHg and/or diastolic blood pressure >110mmHg.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayoshi Kojima |
Organization
Komono Kosei Hospital
Division name
Department of Internal Medicine
Zip code
Address
75 Fukumura, Komono-cho, Mie
TEL
059-393-1212
m-kojima@kkh.miekosei.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayoshi Kojima |
Organization
Komono Kosei Hospital
Division name
Department of Internal Medicine
Zip code
Address
75 Fukumura, Komono-cho, Mie
TEL
059-393-1212
Homepage URL
m-kojima@kkh.miekosei.or.jp
Sponsor or person
Institute
Komono Kosei Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya City university Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2012 | Year | 03 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | 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
| 2012 | Year | 03 | Month | 06 | Day |
Last modified on
| 2014 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008784
