OPTIMAL TREATMENT OF FOCAL AND SEGMENTAL GLOMERULOSCLEROSIS (FSGS)

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objective is to conduct a multi-center, prospective, randomized trial to compare the effectiveness of a treatment regimen including CSA to a regimen including MMF and oral pulse steroids in inducing remission of proteinuria in participants with steroid resistant FSGS. Both of the regimens will also include an ACE inhibitor and alternate day low dose prednisone. On a therapeutic background of alternate day steroids and inhibition of renin angiotensin system, the main research hypotheses are that the participants with steroid resistant ESGS who are treated with MMF/oral pulse dexamethasone will have significantly greater proportion with a) remission of proteinuria after 52 weeks on therapy and/or b) remission of proteinuria 26 weeks after withdrawal of therapy when compared to similar participants receiving CSA. Additional research hypotheses are that one or more of the following will differ between the two therapeutic groups: a) Improved quality of life b) Decreased numbers of adverse events and extrarenal complications c) Preservation of renal function