Cyclosporine and steroid therapy in children with steroid-resistant nephrotic syndrome

Pediatr Nephrol. 2009 Nov;24(11):2177-85. doi: 10.1007/s00467-009-1264-0.

Abstract

We conducted a prospective, multicenter trial to evaluate the efficacy and safety of a 12-month course of cyclosporine in children with steroid-resistant nephrotic syndrome (SRNS). Thirty-five patients were enrolled, of whom 28 had minimal change or diffuse mesangial proliferation (MC/DMP), and seven had focal segmental glomerulosclerosis (FSGS). All patients received cyclosporine and prednisolone; patients with FSGS additionally received methylprednisolone pulse therapy (MPT). The dose of cyclosporine was adjusted to maintain a trough level of 120-150 ng/ml during the initial 3 months of treatment, followed by 80-100 ng/ml during months 4-12. The primary end point was the remission rate at month 12. Remission was achieved in 23 of 28 (82.1%) patients in the MC/DMP group and in six of the seven (85.7%) patients in the FSGS group. Follow-up renal biopsies were performed in 26 patients (nine at month 12, 17 at month 24), and cyclosporine-related nephrotoxicity was detected in one (3.8%). Major adverse events comprised severe bacterial infections (two patients) and posterior reversible encephalopathy syndrome (one patient). In conclusion, a high remission rate was achieved in our patient cohort using a combined cyclosporine/ prednisolone treatment regimen in children with SRNS who had MC/DMP and a combined cyclosporine/prednisolone plus MPT regimen in children who had FSGS.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Biopsy
  • Child
  • Child, Preschool
  • Cyclosporine / therapeutic use*
  • Disease Progression
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Resistance
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Glucocorticoids / therapeutic use
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Infusions, Intravenous
  • Japan
  • Male
  • Methylprednisolone / therapeutic use
  • Nephrotic Syndrome / drug therapy*
  • Nephrotic Syndrome / pathology
  • Prednisolone / therapeutic use
  • Prospective Studies
  • Randomized Controlled Trials as Topic
  • Remission Induction
  • Steroids / metabolism*
  • Time Factors
  • Treatment Outcome

Substances

  • Glucocorticoids
  • Immunosuppressive Agents
  • Steroids
  • Cyclosporine
  • Prednisolone
  • Methylprednisolone