IRB Number:

2263-03

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This research study is being done in association with the National Institutes of Health (NIH) to evaluate the effects (good and bad) of pulse high dose steroids, orally, four times per month in achieving improvement or remission of nephrotic syndrome in patients with Focal Segmental Glomerulosclerosis (FSGS).

Focal segmental glomerulosclerosis (FSGS) and minimal change disease are kidney diseases that are associated with increased excretion of protein in the urine. Approximately half of FSGS patients will lose kidney function within 8 years of diagnosis and will require dialysis.

Who is Eligible to Participate in the Study?

Adults and children over the age of 2 diagnosed with Focal Segmental Glomerulosclerosis (FSGS) may be eligible to participate in this research study.

What is Involved With this Study?

Particpants will receive 48 doses of oral dexamethasone over a period of 48 weeks. One group will take two daily doses every 2 weeks; the other group will take four daily doses every 4 weeks. Doctors will monitor participants before, during, and after the steroid treatment with extensive exams and testing. At the completion of the study, researchers will evaluate the safety and efficacy of the drug treatment.

How long will the Study run?

Particpants will be in the study for a period of 26 months during which they will receive medication beginning at study entry and for each month for 12 months.

Who can I Contact for Additional Information on this Trial?

Mayo Nephrology Collaborative Group web site for more information.">For more information or to participate in this research project please contact the Mayo Nephrology Collaborative Group. at (507) 266-1047.

Please refer to the Mayo Nephrology Collaborative Group web site for more information.">For more information or to participate in this research project please contact the Mayo Nephrology Collaborative Group. at (507) 266-1047.

Please refer to the Mayo Nephrology Collaborative Group web site for more information."> Mayo Nephrology Collaborative Group web site for more information.">For more information or to participate in this research project please contact the Mayo Nephrology Collaborative Group. at (507) 266-1047.

Please refer to the Mayo Nephrology Collaborative Group web site for more information."> Mayo Nephrology Collaborative Group web site for more information."> Mayo Nephrology Collaborative Group web site for more information.">For more information or to participate in this research project please contact the Mayo Nephrology Collaborative Group. at (507) 266-1047.

Please refer to the Mayo Nephrology Collaborative Group web site for more information.">For more information or to participate in this research project please contact the Mayo Nephrology Collaborative Group. at (507) 266-1047.

Please refer to the Mayo Nephrology Collaborative Group web site for more information."> Mayo Nephrology Collaborative Group web site for more information.">For more information or to participate in this research project please contact the Mayo Nephrology Collaborative Group. at (507) 266-1047.

Please refer to the Mayo Nephrology Collaborative Group web site for more information.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 11/29/2005