Faculty Collaboration Database

Follow-up of phase I trial of adalimumab and rosiglitazone in FSGS: III. Report of the FONT study group. BMC Nephrol 2010 Jan 29;11:2

Date

02/02/2010

Pubmed ID

20113498

Pubmed Central ID

PMC2823728

DOI

10.1186/1471-2369-11-2

Scopus ID

2-s2.0-77249165246 (requires institutional sign-in at Scopus site)   26 Citations

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.

Author List

Peyser A, Machardy N, Tarapore F, Machardy J, Powell L, Gipson DS, Savin V, Pan C, Kump T, Vento S, Trachtman H

Author

Cynthia G. Pan MD Adjunct Professor in the Pediatrics department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adalimumab
Adolescent
Adult
Anti-Inflammatory Agents
Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Child
Child, Preschool
Disease Progression
Female
Follow-Up Studies
Glomerular Filtration Rate
Glomerulosclerosis, Focal Segmental
Humans
Hypoglycemic Agents
Infant
Male
Thiazolidinediones
Treatment Outcome
Young Adult