Prospective randomized study of tolerability and efficacy of combination therapy on chronic kidney disease

UMIN ID: UMIN000001052

Registered date:26/02/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic kidney diseases
• Date of first enrollment: 2008/03/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Loosartan and hydrochlorothiazide group
Loosartan and enalapril group
Loosartan and amlodipine group

Outcome(s)

• Primary Outcome: Blood pressure changes at 4 months after the start of combination therapy
• Secondary Outcome: Changes in systolic blood pressure at 4 months after the start of combination therapy Rates of systolic blood pressure change and achievement of goal systolic blood pressure at 4 months after the start of combination therapy Rates of changes in urinary excretion of protein or albumin at 4 months after the start of combination therapy Rates and values of systolic blood pressure at 12 months after the start of combination therapy Rates of changes in urinary excretion of protein or albumin at 12 months after the start of combination therapy Changes in eGFR values at 12 months after the start of combination therapy Rates of achievement of goal blood pressure 12 months after the start of combination therapy Changes in HOMA-R Safety of the drugs throughout the study period

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Diastolic blood pressure is more than 120 mmHg. 2) HbA1cis more than 8.0%. 3) The occurrence of acute myocardial infarction, stroke, and the other vascular diseases within 6 months. 4) The patients who require calcium blocker for ischemic heart disease. 5) The patients with heart failure whose grade is more than NYHA III. 6) The patients with gout or hyperuricemia, which is more than 8.0 mg/dl at the start of the study. 7) Serum creatinine is more than 2.5 mg/dl. 8) AST or ALT is more than three-time of normal upper level 9) Bilateral renal artery stenosis 10) Endocrinological secondary hypertension 11) Autosomal dominant polycystic kidney disease, congenital anomaly of the kidney, unilateral agenesis of the kidney 12) Malignant hypertension 13) Possible or definite case of pregnancy, lactating women 14) The patients with the history of drug allergy to the study drugs.

Related Information

• Primary Sponsor: Kanto District CKD Treatment Study Group
• Source(s) of Monetary Support: The Kidney Foundation