Hypertensive patients with albuminuria under the treatment of the inhibitor of the renin-angiotension system (RAS)
Conditions
Interventions
Placebo is added in patients under the treatment of the RAS inhibitor. If BP does not reach to lower than 130/80 mmHg, other antihypertensive drug than aldosterone antagonist and inhibitor of RAS is
Sponsors
EVALUATE Project office
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients to fulfill all the following condition can participate 1. Outpatient systolic BP is equal or more than130 mmHg and less than 180 mmHg, and/or outpatient diastolic BP is equal or more than 80 mmHg and less than 110 mmHg 2. Urinary albumin/Cr ratio in first morning void urine at pretreatment period (average of 3 continuously-measured values) is equal or more than 30 mg/g and less than 600 mg/g 3. Angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) has been administered for more than 8 weeks when the interim registration is done 4. eGFR is equal or more than 50 mL/min/1.73m2. 5. Age is equal or more than 20 and less than 80 year-old 6. Written informed consent is obtained based on written and oral explanation of physician in charge
Exclusion criteria
Exclusion criteria: 1. Hypertensive emergency that requires intravenous administration of antihypertensives 2. Aldosterone antagonist has been administered within 8 weeks when the interim registration is done 3. Administration of adrenocorticosteroidal drug, immunosuppressant or long-term (equal or more than 2 weeks) administration of non-steroid anti-inflammatory drugs (NSAID) 4. Serum potassium (K) is equal or more than 5.0 mEq/L 5. Fasting blood glucose is equal or more than 126 mg/dL or anti-diabetic drug is administered. 6. Severe liver damage (Child-Pugh Score: class C) 7. 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 8. Cerebrovascular disease occurs within 6 months 9. Pregnant, possible to be pregnant, or willing to be pregnant 10. Past history of severe side effect of aldosterone antagonist, ACE inhibitor or ARB 11. Supplementation of K or administration of K-sparing diuretics, itraconazole, ritonavir, or nelfinavir. 12. Patients who are inadequate by determination of physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent changes in urinary albumin/Cr ratio in first morning void urine from pretreatment period (average of 3 continuously-measured values) to 12 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Urinary albumin/Cr ratio in first morning void urine: Absolute value, percent changes from pretreatment period to each period of treatment, etc. 2. Urinary liver-type free fatty acid-binding protein (L-FABP) 3. Office blood pressure (BP) 4. Serum Cr or 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) 5. Estimated urinary sodium (Na) excretion for a day: Estimated urinary Na excretion for 24 hours (mmol/day) =21.98x{[urinary Na (mEq/L) / urinary Cr (mg/L)] x [-2.04 x age + 14.89 x body weight (kg) +16.14 x height (cm) - 2244.45]}0.392 6. 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) | — |
Countries
Japan
Contacts
Public ContactKatsuyuki Ando
University of Tokyo Graduate School of Medicine Department of Nephrology and Endocrinology
Outcome results
None listed