Unique ID issued by UMIN | UMIN000003455 |
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Receipt number | R000004165 |
Scientific Title | Second choice of antihypertensive drugs for lowering of proteinuria effective combination therapy in CKD trial |
Date of disclosure of the study information | 2010/04/06 |
Last modified on | 2010/04/06 17:29:19 |
Second choice of antihypertensive drugs for lowering of proteinuria effective combination therapy in CKD trial
Second choice of antihypertensive drugs for lowering of proteinuria effective combination therapy in CKD trial(SELECT-CKD TRIAL)
Second choice of antihypertensive drugs for lowering of proteinuria effective combination therapy in CKD trial
Second choice of antihypertensive drugs for lowering of proteinuria effective combination therapy in CKD trial(SELECT-CKD TRIAL)
Japan |
Hypertensive patients with CKD under the treatment of ARB
Medicine in general | Cardiology | Nephrology |
Others
NO
The aim of this study is to evaluate the safety and efficacy of antihypertensive treatment for hypertensive patients with CKD by applying different two patterns of drug treatment following to CKD guide in Japan.
Safety,Efficacy
1. Change in urinary protein
2. Change in baPWV
1 Change in CKD stage
2 Serum Cr
3 Estimated GFR
4 Serum beta2-microglobulin
5 Urinary L-FABP
6 Serum CRP
7 Plasma BNP
8 Echocardiography
9 ICG
10 PAI-1
11 Serum ADMA
12 Serum uric acid
13 Cardiovascular events
Cerebrovascular and cardiovascular mortality fatal myocardial infarction, fatal heart failure, sudden death, fatal stroke, other cardiovascular death
Hospitalization due to cerebrovascular and cardiovascular disease nonfatal myocardial infarction, angina, heart failure, cerebral bleeding, cerebral infarction, transient cerebral ishemic attack
14 Blood pressure lowering effect
15 Heart rate
16 Safety
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is considered as a block.
YES
Numbered container method
2
Treatment
Medicine |
ACE-inhibitor is added on pretreatment(ARB)
Cilnidipine is added on pretreatment(ARB)
20 | years-old | <= |
85 | years-old | > |
Male and Female
Hypertensive patients with CKD fulfilled following conditions during observation period will be enrolled
(targeted)
1. SBP>=130mmHg or DBP>=80mmHg
2. Treated by ARB more than 1 month, and not treated by CCB or ACE inhibitor last 1 month
3. Written informed consent for this study is obtained
4. Obvious Renal damage
1) Proteinuria, pathology diagnostic imaging, urine or blood tests etc.
2) GFR=<60mL/min/1.73m2
Following patients will be excluded from this study
1.Hypertensive emergency that requires other than oral administration of antihypertensives
2.Past history of severe adverse effect by CCB, ARB, or ACE inhibitor
3.Cerebrovascular disease occured within 6 months
4.Severe liver or renal dysfunction
5.Sever heart failure (NYHA class >= 3), severe arrhythmia (frequent ventricular or atrial extrasystole, sustained ventricular tachycardia, atrial arrhythmia with severe tachycardia, atrial fibrillation or flutter with severe bradycardia, sick sinus syndrome with severe bradycardia, atrio-ventricular block with severe bradycardia), myocardial infarction within 6 months
6. Malignancy
7. Pregnant, possible to be pregnant, or willing to be pregnant
8. Scheduling the operation
9. Patients who are inadequate by physician's decision
100
1st name | |
Middle name | |
Last name | Kosaku Nitta |
Tokyo Women's Medical University
Department of Medicine, Kidney Center
8-1 Kawada-cho, Shinjuku-ku, Tokyo
03-3353-8111
1st name | |
Middle name | |
Last name | Tetsuya Ogawa |
Tokyo Women's Medical University
Department of Medicine, Kidney Center
8-1 Kawada-cho, Shinjuku-ku, Tokyo
03-3353-8111
Tokyo Women's Medical University
Tokyo Women's Medical University
Self funding
NO
2010 | Year | 04 | Month | 06 | Day |
Unpublished
Enrolling by invitation
2009 | Year | 07 | Month | 04 | Day |
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 04 | Month | 06 | Day |
2010 | Year | 04 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004165
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