Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis)

PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

December 31, 1999

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions
FibrosisFocal GlomerulosclerosisKidney FailureNephrotic SyndromeProteinuria
Interventions
DRUG

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.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

NCT00001959 - Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis) | Biotech Hunter | Biotech Hunter