Idiopathic focal segmental glomerulosclerosis (FSGS) is a progressive scarring disorder that causes proteinuria and kidney failure in the majority of affected individuals. There is considerable controversy regarding the best therapeutic intervention and the definition of pathological variants of FSGS that may impact therapeutic response rates. This proposal focuses on the design and conduct of a collaborative multicenter trial that will evaluate response rates of children and young adults with the nephrotic syndrome due to FSGS treated with cyclosporin A as compared to corticosteroids plus angiotensin receptor blocker therapy. It will utilize a newly determined FSGS classification scheme as defined by the NY Pathology Consensus Group that includes one of our collaborators. In addition, since incidence of idiopathic FSGS has been increasing over the past 2 decades, a case-control study that will evaluate risk factors for FSGS is proposed to run concurrently with the trial. Our proposed southeastern clinical coordinating center will provide strength to the planned nation-wide trial through our large patient population with FSGS, the strength of the UNC nephropathology service, and the investigators' long track record of clinical trial and epidemiologic research in glomerular diseases through the UNC-Chapel Hill based Glomerular Disease Collaborative Network. In conjunction with committed collaborating sites, our group has over 400 FSGS patients who would be eligible for the proposed trial, as well as established mechanisms for including prospectively identified patients. The proposed case-control study will evaluate risk factors for the development of FSGS such as body mass, birth weight, viral illnesses and smoking in all patients screened for entry into the trial.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK063455-06
Application #
7288376
Study Section
Special Emphasis Panel (ZDK1-GRB-2 (O3))
Program Officer
Moxey-Mims, Marva M
Project Start
2002-09-30
Project End
2009-12-31
Budget Start
2007-09-01
Budget End
2009-12-31
Support Year
6
Fiscal Year
2007
Total Cost
$388,401
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
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Hogg, Ronald J; Friedman, Aaron; Greene, Tom et al. (2013) Renal function and proteinuria after successful immunosuppressive therapies in patients with FSGS. Clin J Am Soc Nephrol 8:211-8
Ferris, Maria; Norwood, Victoria; Radeva, Milena et al. (2013) Patient recruitment into a multicenter randomized clinical trial for kidney disease: report of the focal segmental glomerulosclerosis clinical trial (FSGS CT). Clin Transl Sci 6:13-20
D'Agati, Vivette D; Alster, Joan M; Jennette, J Charles et al. (2013) Association of histologic variants in FSGS clinical trial with presenting features and outcomes. Clin J Am Soc Nephrol 8:399-406
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Trachtman, Howard; Vento, Suzanne; Gipson, Debbie et al. (2011) Novel therapies for resistant focal segmental glomerulosclerosis (FONT) phase II clinical trial: study design. BMC Nephrol 12:8
Ferris, Maria; Patel, Uptal D; Massengill, Susan et al. (2008) Pediatric chronic kidney disease in North Carolina. N C Med J 69:208-14