Two-Year Follow-Up of a Prospective Clinical Trial of Cyclosporine for Frequently Relapsing Nephrotic Syndrome in Children

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 inv...

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Veröffentlicht in:Clinical journal of the American Society of Nephrology 2012-10, Vol.7 (10), p.1576-1583
Hauptverfasser: Ishikura, Kenji, Yoshikawa, Norishige, Nakazato, Hitoshi, Sasaki, Satoshi, Iijima, Kazumoto, Nakanishi, Koichi, Matsuyama, Takeshi, Ito, Shuichi, Yata, Nahoko, Ando, Takashi, Honda, Masataka
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container_issue 10
container_start_page 1576
container_title Clinical journal of the American Society of Nephrology
container_volume 7
creator Ishikura, Kenji
Yoshikawa, Norishige
Nakazato, Hitoshi
Sasaki, Satoshi
Iijima, Kazumoto
Nakanishi, Koichi
Matsuyama, Takeshi
Ito, Shuichi
Yata, Nahoko
Ando, Takashi
Honda, Masataka
description 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. 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). 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
doi_str_mv 10.2215/CJN.00110112
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This study is a prospective follow-up trial after 2-year treatment with cyclosporine to investigate cyclosporine dependency after its discontinuation. 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). 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&lt;0.001). 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By group, the probability of relapse-free survival was significantly higher in group A (17.9%) than in group B (8.3%) (P&lt;0.001). Children with FRNS who receive cyclosporine are at high risk of relapse after discontinuation, particularly those who experience relapse during cyclosporine treatment.</description><subject>Adolescent</subject><subject>Age Factors</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Cyclosporine - administration &amp; dosage</subject><subject>Disease-Free Survival</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Immunosuppressive Agents - administration &amp; dosage</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Japan</subject><subject>Kaplan-Meier Estimate</subject><subject>Male</subject><subject>Nephrotic Syndrome - drug therapy</subject><subject>Nephrotic Syndrome - mortality</subject><subject>Original</subject><subject>Prospective Studies</subject><subject>Recurrence</subject><subject>Risk Factors</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>1555-9041</issn><issn>1555-905X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkd1vFCEUxYmxsbX65rPh0Qen5WOY2b6YmIm1Nk01uk30iTBw2aFhYAqz3Wz_emnabpUQIDk_zr1wEHpHyRFjVBx355dHhFBaJnuBDqgQojoh4vfL3bmm--h1zteE1DVn4hXaZ2zBW9Y2B-huuYnVH1AJn0bv46a6mnC0WOEfKeYJ9OxuAXfeBaeVx8vkylr0bqt90WNyAbCN5XaCmzWE2W_xT_Bqyi6s8CVMQ4qz0_jXNpgUR8Au4G5w3iQIb9CeVT7D28f9EF2dfll2Z9XF96_fus8Xla4XfK64WVhjqG1Ur3tFaKvNom-11Roaak8a2grDW9MKrUQPAKw21vaNqVmvWmENP0SfHnyndT-C0aXLpLyckhtV2sqonPxfCW6Qq3gred1wRkgx-PBokGJ5ZJ7l6LIG71WAuM6SsjJ4zSkr6McHVJfvywnsrgwl8j4uWeKST3EV_P2_re3gp3yeSw9uNWxcAplH5X3BmdTXKof23piKgv4FWZyibg</recordid><startdate>20121001</startdate><enddate>20121001</enddate><creator>Ishikura, Kenji</creator><creator>Yoshikawa, Norishige</creator><creator>Nakazato, Hitoshi</creator><creator>Sasaki, Satoshi</creator><creator>Iijima, Kazumoto</creator><creator>Nakanishi, Koichi</creator><creator>Matsuyama, Takeshi</creator><creator>Ito, Shuichi</creator><creator>Yata, Nahoko</creator><creator>Ando, Takashi</creator><creator>Honda, Masataka</creator><general>American Society of Nephrology</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20121001</creationdate><title>Two-Year Follow-Up of a Prospective Clinical Trial of Cyclosporine for Frequently Relapsing Nephrotic Syndrome in Children</title><author>Ishikura, Kenji ; 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subjects 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
Nephrotic Syndrome - mortality
Original
Prospective Studies
Recurrence
Risk Factors
Time Factors
Treatment Outcome
title Two-Year Follow-Up of a Prospective Clinical Trial of Cyclosporine for Frequently Relapsing Nephrotic Syndrome in Children
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