NIPH Clinical Trials Search

UMIN ID: UMIN000001247

Registered date:14/07/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedHypertension with diabetic nephropathy
Date of first enrollment2008/04/01
Target sample size500
Countries of recruitmentJapan
Study typeInterventional
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)


Primary OutcomeChange in urinary albumin-creatinine ratio (mg/g*Cr)
Secondary Outcome1) 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 minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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


public contact
Name Department of EBM Research
Address Syogoinkawaharamachi 54, Sakyo-ku, Kyoto Japan
Telephone 0120105894
Affiliation Kyoto university Hospital iACT
scientific contact
Name Toshiro FUJITA
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo Japan
Telephone 03
Affiliation The University of Tokyo Graduate School of Medicine Department of Nephrology and Endocrinology