Document Detail


Two-year follow-up of a prospective clinical trial of cyclosporine for frequently relapsing nephrotic syndrome in children.
MedLine Citation:
PMID:  22837276     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND AND OBJECTIVES: 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.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: 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:
Kenji Ishikura; Norishige Yoshikawa; Hitoshi Nakazato; Satoshi Sasaki; Kazumoto Iijima; Koichi Nakanishi; Takeshi Matsuyama; Shuichi Ito; Nahoko Yata; Takashi Ando; Masataka Honda;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2012-07-26
Journal Detail:
Title:  Clinical journal of the American Society of Nephrology : CJASN     Volume:  7     ISSN:  1555-905X     ISO Abbreviation:  Clin J Am Soc Nephrol     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-08     Completed Date:  2013-03-22     Revised Date:  2013-10-17    
Medline Journal Info:
Nlm Unique ID:  101271570     Medline TA:  Clin J Am Soc Nephrol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1576-83     Citation Subset:  IM    
Affiliation:
Department of Nephrology, Tokyo Metropolitan Children's Medical Center, Fuchu, Japan. kenji_ishikura@tmhp.jp
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Age Factors
Child
Child, Preschool
Cyclosporine / administration & dosage*
Disease-Free Survival
Drug Administration Schedule
Female
Follow-Up Studies
Humans
Immunosuppressive Agents / administration & dosage*
Infant
Infant, Newborn
Japan
Kaplan-Meier Estimate
Male
Nephrotic Syndrome / drug therapy*,  mortality
Prospective Studies
Recurrence
Risk Factors
Time Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Immunosuppressive Agents; 59865-13-3/Cyclosporine
Comments/Corrections

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