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Open Access Highly Accessed Research article

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

Alexandra Peyser1, Nathaniel MacHardy2, Freya Tarapore1, Jacqueline MacHardy2, Leslie Powell2, Debbie S Gipson2, Virginia Savin3, Cynthia Pan4, Theresa Kump4, Suzanne Vento1 and Howard Trachtman1*

Author Affiliations

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, 7012-A Burnett-Womack Building, CB #7155, University of North Carolina at Chapel Hill, 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

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BMC Nephrology 2010, 11:2  doi:10.1186/1471-2369-11-2

Published: 29 January 2010

Abstract

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.