21
Participants
Start Date
December 31, 1999
Primary Completion Date
October 31, 2008
Study Completion Date
October 31, 2008
Pirfenidone
During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH