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

BMC Nephrology

Research Article

Virginia Savin¹  Cynthia Pan²  Theresa Kump²  Freya Tarapore³  Alexandra Peyser³  Howard Trachtman³  Suzanne Vento³  Nathaniel MacHardy⁴  Leslie Powell⁴  Jacqueline MacHardy⁴  Debbie S Gipson⁴ 

[1] Department of Medicine, Division of Nephrology, Medical College of Wisconsin, 8701 Watertown Plank Road, 53226, Milwaukee, WI, USA;Department of Pediatrics, Division of Nephrology, Children's Hospital of Wisconsin, 999 North 92nd Street, 53227, Wauwatosa, WI, USA;Department of Pediatrics, Division of Nephrology, Schneider Children's Hospital of North Shore-LIJ Health System, 269-01 76th Avenue, 11040, New Hyde Park, NY, USA;Division of Nephrology and Hypertension, Unversity of North Carolina Kidney Center, University of North Carolina at Chapel Hill, 7012-A Burnett-Womack Building, CB #7155, 27599, Chapel Hill, NC, USA;

关键词: Renal Replacement Therapy;    Adalimumab;    Rosiglitazone;    Angiotensin Converting Enzyme Inhibitor;    Angiotensin Receptor Blocker;   

DOI  :  10.1186/1471-2369-11-2

 received in 2009-10-02, accepted in 2010-01-29,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundPatients 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.Methods21 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.Results19 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).ConclusionNearly 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.

【 授权许可】

Unknown   
© Peyser et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.