Protocol Number: 01-DK-0053
Patients 18 years of age and older with FSGS may be eligible for this study, including those 1) who have not been treated; 2) who require steroids to prevent a return of proteinuria; 3) whose proteinuria did not respond to steroid treatment; 4) who had a recurrence of FSGS after having a kidney transplant; and 5) who are on dialysis and are considering kidney transplantation. All study participants will have 1 teaspoon of blood drawn to measure permeability factor and perform other tests related to FSGS. Additional samples may be requested if levels of the protein are very low or very high. Patients who have recurrent FSGS following a kidney transplant may choose to 1) continue on their present immunosuppressive drugs; 2) try to treat the FSGS directly with plasma exchange; or 3) try to treat the FSGS directly with plasma exchange plus cyclophosphamide, an immune-suppressing medicine. Plasma exchange is the removal of plasma (the fluid part of the blood) and replacement with a human albumin solution. This procedure may effectively remove the permeability factor from the plasma of patients with FSGS. Plasma exchange is done by a procedure called apheresis. In this procedure, whole blood is drawn through a needle in the forearm or by another method, the plasma is separated from the blood cells and removed, and the cells are returned to the patient through a second needle. Plasma exchange usually requires four to six apheresis procedures, each lasting about 2 hours. Cyclophosphamide, which is approved to treat some leukemias, is also commonly used for FSGS. This drug might lower production of permeability factor, thereby reducing kidney damage. Patients with good kidney function will take standard doses of cyclophosphamide by mouth for 3 months. Patients with impaired kidney function will receive 75 percent of the standard dose for 3 months. Patients with kidney failure who have elevated levels of permeability factor and are considering a kidney transplant will undergo plasma exchange. If their permeability factor levels rise again, they will have a second course of plasma exchange plus cyclophosphamide.
All patients with elevated permeability factor who undergo treatment for FSGS may be asked to give 1 teaspoon of blood every month or every 3 months while undergoing treatment and then every 3 months for a year after therapy ends to see what treatments successfully reduce protein levels.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 05/05/2009
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