%0 Journal Article
%T Follow-up of phase I trial of adalimumab and rosiglitazone in FSGS: III. Report of the FONT study group
%A Alexandra Peyser
%A Nathaniel MacHardy
%A Freya Tarapore
%A Jacqueline MacHardy
%A Leslie Powell
%A Debbie S Gipson
%A Virginia Savin
%A Cynthia Pan
%A Theresa Kump
%A Suzanne Vento
%A Howard Trachtman
%J BMC Nephrology
%D 2010
%I BioMed Central
%R 10.1186/1471-2369-11-2
%X 21 patients -- 12 males and 9 females, age 16.0 ¡À 7.5 yr, and estimated GFR (GFRe) 121 ¡À 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.19 patients completed the 16-week FONT treatment phase. The observation period pre-FONT was 18.3 ¡À 10.2 months and 16.1 ¡À 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).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.Primary focal segmental glomerulosclerosis (FSGS) is increasing in frequency throughout the world [1]. It usually presents with isolated proteinuria or overt nephrotic syndrome in both pediatric and adult patients [2-4]. The cause of this glomerulopathy remains unknown and there are no proven treatments that consistently induce complete remission of proteinuria [5]. Patients who are resistant to corticosteroids and other immunosuppressive medications are at substantial risk of progression to chronic kidney disease (CKD) stage V [6-8]. There is an urgent need to develop new strategies to delay or prevent loss of renal function in this patient cohort.The primary purpose of the first portion of the Novel Therapies for Resistant FSGS (FONT) study is to evaluate the safety, tolerability, and pharmacokinetic characteristics o
%U http://www.biomedcentral.com/1471-2369/11/2