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Effective and safe treatment with cyclosporine in nephrotic children: a prospective, randomized multicenter trial

K Ishikura1, M Ikeda, S Hattori

  • 1Department of Pediatric Nephrology, Tokyo Metropolitan Kiyose Children's Hospital, Tokyo, Japan. kenzo@ii.e-mansion.com

Kidney International
|February 29, 2008
PubMed

Insights

Cyclosporine effectively treats frequently relapsing nephrotic syndrome in children. Maintaining targeted blood levels of cyclosporine (a whole-blood trough level) led to higher sustained remission rates and fewer relapses compared to a fixed dose.

Area of Science:

  • Pediatric Nephrology
  • Immunosuppressive Therapy

Background:

  • Frequently relapsing nephrotic syndrome (FRNS) in children poses significant treatment challenges.
  • Current therapies for FRNS often involve long-term immunosuppression with potential side effects.

Purpose of the Study:

  • To evaluate the efficacy and safety of cyclosporine in treating pediatric FRNS.
  • To compare two different cyclosporine dosing strategies: targeted trough levels versus a fixed dose.

Main Methods:

  • Prospective, open-label, multicenter trial involving children with FRNS.
  • Randomized patients into two groups receiving cyclosporine: Group A (targeted trough levels 60-80 ng/ml) and Group B (fixed dose 2.5 mg/kg/day).
  • Primary endpoint was the rate of sustained remission over a 2-year period.

Main Results:

  • Group A demonstrated a significantly higher rate of sustained remission compared to Group B.
  • The hazard ratio for relapse was significantly lower in Group A.
  • Mild arteriolar hyalinosis was observed more frequently in Group A, but no severe renal pathology was noted.

Conclusions:

  • Targeted trough level monitoring of cyclosporine is an effective strategy for managing pediatric FRNS.
  • Cyclosporine, when dosed to maintain specific blood levels, offers a relatively safe and effective treatment option for children with FRNS.

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