COmbination Strategy on renal function of the benidipine or diuretics treatMent with RAS inhibitOrs in CKD hypertensive population

UMIN ID: UMIN000002143

Registered date:01/07/2009

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hypertensive patients with albuminuria under the treatment of the inhibitor of the renin-angiotension system (RAS)
• Date of first enrollment: 2009/07/01
• Target sample size: 400
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Benidipine (4 to 8 mg/day) is added in patients with the treatment of the RAS inhibitor. If BP does not reach to lower than 130/80 mmHg, other antihypertensive drug than CCB, diuretic and RAS inhibitor is added.
Hydrochlorthiazide (6.25 to 12.5 mg/day) is added in patients with the treatment of the RAS inhibitor. If BP does not reach to lower than 130/80 mmHg, other antihypertensive drug than CCB, diuretic and RAS inhibitor is added.

Outcome(s)

• Primary Outcome: Changes in urinary albumin/ creatinine(Cr) ratio in spot urine from pretreatment period (average of 2 measured value) to 12 months of treatment
• Secondary Outcome: 1. Urinary albumin/Cr ratio in fspot urine: Percent changes from pretreatment period to each period of treatment, etc. 2. Estimated glomerular filtration rate (eGFR) calculated using the modified MDRD formula in the Japanese Society of Nephrology: eGFR (ml/min/1.73 m2) = 194 x age -0.287 x serum Cr - 1.094 (multiply by 0.739 in female) 3. Urinary liver-type free fatty acid-binding protein (L-FABP) 4. Serum Cr 5. Blood urea nitrogen (BUN) 6. Office blood pressure (BP) 7. Pulse rate 8. Renal events: Start of dialysis, renal transplantation 9. Cerebro-cardio-vascular events: Cerebro-cardio-vascular death (fatal myocardial infarction, fatal heart failure, sudden death, fatal stroke, other cardiovascular death) and hospitalization due to cerebro-cardio-vascular disease (nonfatal myocardial infarction, angina, heart failure, cerebral bleeding, cerebral infarction, transient cerebral ischemic attack)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Patients who apply any of the flowing condition cannot participate 1. Outpatient systolic BP is equal or more than 180 mmHg and/or outpatient diastolic BP is equal or more than 110 mmHg. Or hypertensive emergency that requires intravenous administration of antihypertensives 2. Administration of adrenocorticosteroidal drug, immunosuppressant or long-term (equal or more than 2 weeks) administration of non-steroid anti-inflammatory drugs (NSAID) 3. Past history of severe side effect of CCB, thiazide diretic, ARB or ACE inhibitor 4. 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 5. Cerebrovascular disease occurs within 6 months 6. Sever heart failure (NYHA class is equal or more than III), severe arrhythmia (frequent ventricular or atrial extrasystole, prolonged ventricular tachycardia, atrial tachyrhythmia with severe tachycardia, atrial fibrillation or flutter with severe tachycardia, sick sinus syndrome with severe bradycardia, atrio-ventricular block with severe bradycardia), angina, or myocardial infarction within 6 months 7. AST or ALT is more than 5 times higher upper limits 8. Pregnant, possible to be pregnant, or willing to be pregnant 9. Patients who are inadequate by determination of physician in charge

Related Information

• Primary Sponsor: COSMO-CKD Study Group
• Source(s) of Monetary Support: The Kidney Foundation of Japan Inc.