Follow-up of phase I trial of adalimumab and rosiglitazone in FSGS: III. Report of the FONT study group

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• 作者：Alexandra Peyser (1)
  Nathaniel MacHardy (2)
  Freya Tarapore (1)
  Jacqueline MacHardy (2)
  Leslie Powell (2)
  Debbie S Gipson (2)
  Virginia Savin (3)
  Cynthia Pan (4)
  Theresa Kump (4)
  Suzanne Vento (1)
  Howard Trachtman (1)
  
• 刊名：BMC Nephrology
• 出版年：2010
• 出版时间：December 2010
• 年：2010
• 卷：11
• 期：1
• 全文大小：428KB
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  11. Joy MS, Gipson DS, Dike M, Powell L, Thompson A, Vento S, Eddy E, Fogo AB, Kopp JB, Cattran D, Trachtman H: Phase I trial of rosiglitazone in FSGS: I. Report of the FONT study group. / Clin J Am Soc Nephrol 2009, 4:39-7. CrossRef
  12. Joy MS, Gipson DS, Powell L, MacHardy J, Jennette JC, Vento S, Pan C, Savin V, Eddy E, Fogo AB, Kopp JB, Cattran D, Trachtman H: Phase I trial of adalimumab in focal segmental glomerulosclerosis (FSGS): II. Report of the FONT (Novel therapies for resistant FSGS) study group. / Am J Kidney Dis 2010, 55:50-0. CrossRef
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  22. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2369/11/2/prepub
  
• 作者单位：Alexandra Peyser (1)
  Nathaniel MacHardy (2)
  Freya Tarapore (1)
  Jacqueline MacHardy (2)
  Leslie Powell (2)
  Debbie S Gipson (2)
  Virginia Savin (3)
  Cynthia Pan (4)
  Theresa Kump (4)
  Suzanne Vento (1)
  Howard Trachtman (1)
  
  1. Department of Pediatrics, Division of Nephrology, Schneider Children's Hospital of North Shore-LIJ Health System, 269-01 76th Avenue, New Hyde Park, NY, 11040, USA
  2. Unversity of North Carolina Kidney Center, Division of Nephrology and Hypertension, University of North Carolina at Chapel Hill, 7012-A Burnett-Womack Building, CB #7155, Chapel Hill, NC, 27599, USA
  3. Department of Medicine, Division of Nephrology, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, WI, 53226, USA
  4. Department of Pediatrics, Division of Nephrology, Children's Hospital of Wisconsin, 999 North 92nd Street, Wauwatosa, WI, 53227, USA
  

文摘

Background Patients with resistant primary focal segmental glomerulosclerosis (FSGS) are at high risk of progression to chronic kidney disease stage V. Antifibrotic agents may slow or halt this process. We present outcomes of follow-up after a Phase I trial of adalimumab and rosiglitazone, antifibrotic drugs tested in the Novel Therapies in Resistant FSGS (FONT) study. Methods 21 patients -- 12 males and 9 females, age 16.0 ± 7.5 yr, and estimated GFR (GFRe) 121 ± 56 mL/min/1.73 m2 -- received adalimumab (n = 10), 24 mg/m2 every 14 days or rosiglitazone (n = 11), 3 mg/m2 per day for 16 weeks. The change in GFRe per month prior to entry and after completion of the Phase I trial was compared. Results 19 patients completed the 16-week FONT treatment phase. The observation period pre-FONT was 18.3 ± 10.2 months and 16.1 ± 5.7 months after the study. A similar percentage of patients, 71% and 56%, in the rosiglitazone and adalimumab cohorts, respectively, had stabilization in GFRe, defined as a reduced negative slope of the line plotting GFRe versus time without requiring renal replacement therapy after completion of the FONT treatment period (P = 0.63). Conclusion Nearly 50% of patients with resistant FSGS who receive novel antifibrotic agents may have a legacy effect with delayed deterioration in kidney function after completion of therapy. Based on this proof-of-concept preliminary study, we recommend long-term follow-up of patients enrolled in clinical trials to ascertain a more comprehensive assessment of the efficacy of experimental treatments.