Investigation of an efficacy of eplerenone combined therapy for hypertensive patients with chronic kidney disease that enough hypotensive effect are not obtained with an angiotensin receptor blocker

Not Applicable

• Conditions: Hypertensive patients with chronic kidney disease that enough hypotensive effect is not obtained with an angiotensin receptor blocker

• Registration Number: JPRN-UMIN000005956
• Lead Sponsor: OWASE study Project Office

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

1. Uncontrolled hypertension (systolic blood pressure is equal or more 220 mmHg, or diastolic blood pressure is equal or more 110 mmHg) 2. Unstable angina pectoris 3. Myocardial infarction occurs within 6 months 4. Severe heart failure (NYHA class is equal or more than III) 5. Severe arrhythmia (frequent ventricular or atrial extrasystole, prolonged ventricular tachycardia, atrial tachyarrhythmia, atrial fibrillation, atrial flutter, sick sinus syndrome or atrio-ventricular block) 6. eGFR is less than 36mL/min/1.73m2 7. Severe liver dysfunction or Child-Pugh class score is C 8. Active cancer 9. Serum potassium is equal or more than 5 mEq/L 10. Diabetic patients with microalbuminuria (urinary albumin/creatinine ratio is equal or more than 30mg/gCr) or proteinuria 11. Supplementation of K or administration of K-sparing diuretics 12. Administration of itraconazole, ritonavir or nelfinavir 13. Administration of steroid or immunosuppressant 14. Pregnant, possible to be pregnant 15. Patient who is already treated for study drugs 16. Patients with allergy or contraindication to study drugs 17. Patients that it is impossible to get an agreement 18. Patients who are inadequate by determination of physician in charge

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in urinary albumin/creatinine ratio from pretreatment period to 12 months of treatment

Secondary Outcome Measures

Name	Time	Method
1. Change in office blood pressure 2. Change in estimated glomerular filtration rate (eGFR) 3. Change in urinary protein 4. Change in brachial-ankle pulse wave velocity (baPWV) 5. Change in BNP 6. Change in cardiac ultrasonography findings (ejection fraction, E', A', E/E', left ventricukar mass) 7. Cerebro-cardio-vascular events (all death, non-fatal myocardial infarction, angina pectoris, stroke, heart failure) 8. Side effect of eplerenone or thiazide diuretics