Study of Assessment for Kidney function by Urinary microalbumin in RAndomized Trial

UMIN ID: UMIN000001247

Registered date:14/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypertension with diabetic nephropathy
• Date of first enrollment: 2008/04/01
• Target sample size: 500
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

amlodipine (initial dose is 5mg/day, but 2.5-10mg is available depending on the effect of blood pressure reduction)
cilnidipine (initial dose is 10mg/day, but 5-20mg is available depending on the blood pressure level)

Outcome(s)

• Primary Outcome: Change in urinary albumin-creatinine ratio (mg/g*Cr)
• Secondary Outcome: 1) urinary albumin-creatinine ratio (mg/g*Cr), 2) stage of chronic kidney disease (CKD), 3) serum creatinine level, 4) estimated glomerular filtration rate, 5) cardiovascular event, 6) antihypertensive effect, 7) heart rate, 8) safety parameters

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) hypertensive emergency, 2) nephropathy due to other than diabetes, 3) history of severe side effects of a CCB, an ARB or an ACE inhibitor, 4) cerebrovascular disease within 6 months of the start of the trial, 5) severe heart failure (New York heart Association classes III and IV), severe arrhythmia, and myocardial infarction within 6 months of the start of the trial, 6) AST and ALT 5 times and more the upper limit of institution's normal, 7) pregnancy, 8) prior use of corticosteroids, immunosuppresants, or nonsteroidal anti-inflammatory drugs (NAISDs), 9) patients who are inadequate to enter this study due to the other reasons by physician's judgments

Related Information

• Primary Sponsor: The University of Tokyo Graduate School of Medicine
• Source(s) of Monetary Support: Department account fund