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Phase I trial of rosiglitazone in FSGS: I. Report of the FONT Study Group

Melanie S Joy1, Debbie S Gipson, Mary Dike

  • 1University of North Carolina at Chapel Hill, University of North Carolina Kidney Center and Division of Nephrology and Hypertension, Chapel Hill, NC, USA.

Clinical Journal of the American Society of Nephrology : CJASN
|December 17, 2008
PubMed
Abstract

Insights

Rosiglitazone was safe and well-tolerated in patients with resistant focal segmental glomerulosclerosis (FSGS). Pharmacokinetic studies suggest further investigation into rosiglitazone

Area of Science:

  • Nephrology
  • Pharmacology
  • Clinical Trials

Background:

  • Primary focal segmental glomerulosclerosis (FSGS) resistant to standard therapy carries a high risk of progressive chronic kidney disease.
  • Preventing renal fibrosis is a key strategy to slow kidney function decline in FSGS patients.
  • Rosiglitazone, a thiazolidinedione, has demonstrated antifibrotic effects in animal models of FSGS.

Purpose of the Study:

  • To assess the safety and tolerability of rosiglitazone in patients with resistant FSGS.
  • To evaluate the pharmacokinetics (PK) of rosiglitazone in this patient population.
  • To establish a rationale for future efficacy trials of rosiglitazone for resistant FSGS.

Main Methods:

  • A Phase I clinical trial involving eleven patients (mean age 15 +/- 6 years) with resistant FSGS.
  • Patients received rosiglitazone at a dose of 3 mg/m(2)/day for 16 weeks.
  • Pharmacokinetic assessments were conducted after the initial dose and at steady state.

Main Results:

  • Rosiglitazone was found to be safe and well-tolerated, with no serious adverse events or cardiovascular complications reported.
  • Pharmacokinetic studies revealed a 40-50% decrease in the area under the curve and a 250-300% increase in oral clearance of rosiglitazone compared to controls.
  • Patient-reported outcomes indicated good tolerability as assessed by the Treatment Satisfaction Questionnaire for Medication.

Conclusions:

  • Rosiglitazone therapy demonstrated safety and good tolerability in patients with resistant FSGS.
  • Pharmacokinetic data are essential for determining appropriate dosing regimens for novel therapies in resistant FSGS.
  • Further Phase II/III clinical trials are warranted to evaluate the efficacy of rosiglitazone as an antifibrotic agent for resistant FSGS.

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