Unique ID issued by UMIN | UMIN000004304 |
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Receipt number | R000005160 |
Scientific Title | Renoprotective effect of Calcium channel blocker or Diuretics treatment with Renin-Angiotensin system(RAS) inhibitor in hypertensive patients with chronic kidney disease(CKD) (CD Study) |
Date of disclosure of the study information | 2010/10/01 |
Last modified on | 2013/10/01 21:33:31 |
Renoprotective effect of Calcium channel blocker or Diuretics treatment with Renin-Angiotensin system(RAS) inhibitor in hypertensive patients with chronic kidney disease(CKD) (CD Study)
CD Study
Renoprotective effect of Calcium channel blocker or Diuretics treatment with Renin-Angiotensin system(RAS) inhibitor in hypertensive patients with chronic kidney disease(CKD) (CD Study)
CD Study
Japan |
Hypertensive patients with CKD under the treatment of the inhibitor of the renin-angiotensin system(RAS)
Medicine in general | Nephrology |
Others
NO
To compare the antialbuminuric effect between long acting calcium channel blocker(CCB) azelnidipine (8 to 16 mg/day) and thiazide diuretic trichlormethiazide (0.5 to 1 mg/day) as addition of RAS inhibitor in hypertensive patients with CKD.
Efficacy
Confirmatory
Pragmatic
Not applicable
Changes in urinary albumin/creatinine(Alb/Cr) ratio in early morning samples from pretreatment period to 12 months of treatment
1. blood pressure(Office, Home)
2. Pulse rate(Home)
3. Change in the urinary Alb/Cr ratio
4. Change in eGFR
5. Relationship between BMI and BP/urinary Alb/Cr ratio
6. Change in HbA1c levels
7. Change in urinary excretion of sodium
8. Change in serum uric acid
9. Change in urinary megalin and urine podocalyxin
10. Cerebro-cardio-vascular events
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 |
Azelnidipine(8 to 16mg/day) is added in patients with the treatment of the RAS inhibitor.If BP dose not reach to lower than 130/80mmHg, other antihypertensive drug except CCB, diuretic and RAS inhibitor is added.
Trichlormethiazide(0.5 to 1mg/day) is added in patients with the treatment of the RAS inhibitor. If BP dose not reach to lower than 130/80mmHg, other antihypertensive drug except CCB, diuretic and RAS inhibitor is added.
20 | years-old | <= |
85 | years-old | > |
Male and Female
Outpatients to fulfill all the following condition can participate
1) Outpatient systolic BP is equal or more than 130 and less than 180 and/or outpatient diastolic BP is equal or more than 85 and less than 110 mmHg.
2) Outpatients with CKD
3) eGFR is more than 30 mL/min/1.73m2.
4) Age is equal or more than 20 and less than 85 year-old.
5) RAS inhibitor has been administered for more than 3 months and CCB and diureteic have not been given within 3 months.
6) Written informed consent is obtained based on written and oral explanation of physician in charge.
1) Secondary hypertension or malignant hypertension(within hypertension in level 3)
2) Severe heart failure(NYHA Class is equal or more than III)
3) Atrial fibrillation or flutter with severe arrhythmia
4) Severe renal failure or liver failure(patient on dialysis, AST or ALT is more than 5 times higher upper limits)
5) Not appropriate for change to the test drugs from current therapy for coronary disease(i.e. CCB, diuretics, etc.)
6) Patient with severe adverse effects by RAS inhibitor, CCB and diuretic
7) Patient has merged the disease seems to be bad, such as malignant tumor prognosis.
8) Type 1 diabetes and type 2 diabetes required hospitalization due to high hemoglobin A1c(equal and more than 9.0%), extremely high blood glucose, or diabetic ketoacidosis.
9) Patients already used other CCB or a diuretic.
10) Pregnant, possible to be pregnant, or willing to be pregnant
11) Patients who are inadequate by determination of physician in charge
300
1st name | |
Middle name | |
Last name | Ichiei Narita |
Niigata University Graduate School of Medical and Dental Sciences
Division of Clinical Nephrology and Rheumatology
1-757 Asahimachi-dori, chuo-ku,Niigata 951-8510, Japan
025-227-2200
naritai@med.niigata-u.ac.jp
1st name | |
Middle name | |
Last name | Emiko Kouno |
Niigata University Graduate School of Medical and Dental Sciences
Division of Clinical Nephrology and Rheumatology
1-757 Asahimachi-dori, chuo-ku,Niigata 951-8510, Japan
025-227-2200
e-kouno@med.niigata-u.ac.jp
Niigata University
none
Self funding
NO
青柳医院(新潟県)、五十嵐医院(新潟県)、岡田内科医院(新潟県)、きくち内科医院(新潟県)、岡田内科医院(新潟県)、井上内科医院(新潟県)、前田内科医院(新潟県)
、安田診療所(新潟県)、ほしの医院(新潟県)、筒井内科クリニック(新潟県)、東新潟病院(新潟県)、林内科クリニック(新潟県)、中新潟クリニック(新潟県)、笹川医院(新潟県)、花野内科医院(新潟県)、田邊医院(新潟県)、新潟県立津川病院(新潟県)、下越病院(新潟県)、阿賀町上川診療所(新潟県)、豊栄病院(新潟県)、えきまえクリニック 内科はやし医院(新潟県)、わかばやし内科クリニック(新潟県)、済生会新潟第二病院(新潟県)、木戸病院(新潟県)水原郷病院(新潟県)、こばりファミリークリニック(新潟県)、三浦クリニック(新潟県)、新潟医療センター病院(新潟県)
2010 | Year | 10 | Month | 01 | Day |
Unpublished
Completed
2010 | Year | 09 | Month | 30 | Day |
2010 | Year | 10 | Month | 01 | Day |
2013 | Year | 05 | Month | 01 | Day |
2010 | Year | 09 | Month | 30 | Day |
2013 | Year | 10 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005160
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