The renoprotective effects of ARB in patients with IgA nephropathy : multicenter,radomized trial

UMIN ID: C000000380

Registered date:31/03/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: IgA nephropathy
• Date of first enrollment: 2003/04/01
• Target sample size: 400
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

ARB valsartan
ACE-I enalapril

Outcome(s)

• Primary Outcome: 1)change in Ccr,2)inverse of inclination of serum Cr value, 3)change in urinary protein excretion, 4)inidence of events (doubling of serum creatinine concentration, 50% decrease in Ccr from the baseline value, dialysis)
• Secondary Outcome: 1)change in PRA and PCA, 2)hyperkalemia, 3)tolerability (drug discontinuation rate)

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1)patients with nephrotic syndorome. 2)patients who administered steroid or discontinuted within 6 months prior to enrolment in the study. 3)patients with serious liver dysfunction. 4)pregnant women or women of child bearing potential and nursing women. 5)patients with hypersensitivity to angiotensin II receptor blocker and angiotensin convertig enzyme inhibitor. 6)Other patients who are judged to be inappropriate for the study by the investigator or subinvestigator.

Related Information

• Primary Sponsor: ARB therapeutic society of IgA nephropathy
• Source(s) of Monetary Support: The Kidney Foundation,Japan