Focal Segmental Glomerulosclerosis Clinical Trial (FSGS-CT)

PHASE3CompletedINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

November 30, 2004

Primary Completion Date

October 31, 2009

Study Completion Date

October 31, 2009

Conditions
Glomerulosclerosis, Focal
Interventions
DRUG

Cyclosporin

Participants assigned to this group will initiate treatment with CSA, 5-6 mg/kg per day with a 250 mg/day maximum starting dose, divided into two daily doses. The CSA dose will be adjusted based on drug levels determined at specified study visits in order to achieve a 12-hour trough concentration in the therapeutic range of 100-250 ng/ml.

DRUG

MMF and Dexamethasone

"MMF, 25-36 mg/kg per day with a maximum dose of 2 g/day divided into two daily doses. The dose range reflects the use of fixed size (250 mg) capsules and application of defined daily doses to specific weight ranges (see Table below). In younger children or those participants who are unable to swallow capsules, a liquid formulation will be used to provide 36 mg/kg per day to a maximum of 2 g per day. The starting MMF dose will be 0.5-0.67 of the full dose for 2 weeks before advancing to the full dose for the duration of the 12-month treatment period.~Dexamethasone, 0.9 mg/kg per dose, with a maximum dose of 40 mg"

Trial Locations (1)

44195-5196

Data Coordinating Center; Cleveland Clinic Foundation; Quantitative Health Sciences; 9500 Euclid Avenue, Cleveland

All Listed Sponsors
collaborator

The Cleveland Clinic

OTHER

lead

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

NIH

NCT00135811 - Focal Segmental Glomerulosclerosis Clinical Trial (FSGS-CT) | Biotech Hunter | Biotech Hunter