title: Two-year follow-up of a prospective clinical trial of cyclosporine for frequently relapsing nephrotic syndrome in children.
abstract: OBJECTIVE
  Although the safety and efficacy of cyclosporine in children with frequently relapsing nephrotic syndrome (FRNS) have been confirmed, no prospective follow-up data on relapse after cyclosporine have appeared. This study is a prospective follow-up trial after 2-year treatment with cyclosporine to investigate cyclosporine dependency after its discontinuation.
  
  
  METHODS
  Participants who had undergone 2-year protocol treatment with microemulsified cyclosporine for FRNS between January 2000 and December 2005 were followed for an additional 2 years. The primary end point was relapse-free survival after the complete discontinuation of cyclosporine, and the secondary end point was regression-free survival (time to regression to FRNS).
  
  
  RESULTS
  After exclusion of 7 patients who showed regression to FRNS during the 2-year treatment period, 49 children (median age, 6.5 years) were followed, and classified as children without (n=32; group A) and with (n=17; group B) relapse during the initial cyclosporine treatment. Overall, relapse-free survival probability at 24 months after cyclosporine discontinuation was 15.3% and regression to FRNS-free survival probability was 40.8%. By group, the probability of relapse-free survival was significantly higher in group A (17.9%) than in group B (8.3%) (P<0.001).
  
  
  CONCLUSIONS
  Children with FRNS who receive cyclosporine are at high risk of relapse after discontinuation, particularly those who experience relapse during cyclosporine treatment.
authors: Department of Nephrology, Tokyo Metropolitan Children's Medical Center, Fuchu, Japan. kenji_ishikura@tmhp.jp
authors: Kenji
authors: K
authors: Ishikura
authors: Norishige
authors: N
authors: Yoshikawa
authors: Hitoshi
authors: H
authors: Nakazato
authors: Satoshi
authors: S
authors: Sasaki
authors: Kazumoto
authors: K
authors: Iijima
authors: Koichi
authors: K
authors: Nakanishi
authors: Takeshi
authors: T
authors: Matsuyama
authors: Shuichi
authors: S
authors: Ito
authors: Nahoko
authors: N
authors: Yata
authors: Takashi
authors: T
authors: Ando
authors: Masataka
authors: M
authors: Honda
mesh_terms: D000293:Adolescent; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D016572:Cyclosporine / Q000008:administration & dosage*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007223:Infant; D007231:Infant, Newborn; D007564:Japan; D053208:Kaplan-Meier Estimate; D008297:Male; D009404:Nephrotic Syndrome / Q000188:drug therapy* / Q000401:mortality; D011446:Prospective Studies; D012008:Recurrence; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine