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 |
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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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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<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><identifier>ISSN: 1555-9041</identifier><identifier>EISSN: 1555-905X</identifier><identifier>DOI: 10.2215/CJN.00110112</identifier><identifier>PMID: 22837276</identifier><language>eng</language><publisher>United States: American Society of Nephrology</publisher><subject>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</subject><ispartof>Clinical journal of the American Society of Nephrology, 2012-10, Vol.7 (10), p.1576-1583</ispartof><rights>Copyright © 2012 by the American Society of Nephrology 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c483t-3d8fdd1f6abcba017cd8b7cfcce61f96175d37d75ca5beee24dffb6d42ba75fd3</citedby><cites>FETCH-LOGICAL-c483t-3d8fdd1f6abcba017cd8b7cfcce61f96175d37d75ca5beee24dffb6d42ba75fd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3463200/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3463200/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22837276$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ishikura, Kenji</creatorcontrib><creatorcontrib>Yoshikawa, Norishige</creatorcontrib><creatorcontrib>Nakazato, Hitoshi</creatorcontrib><creatorcontrib>Sasaki, Satoshi</creatorcontrib><creatorcontrib>Iijima, Kazumoto</creatorcontrib><creatorcontrib>Nakanishi, Koichi</creatorcontrib><creatorcontrib>Matsuyama, Takeshi</creatorcontrib><creatorcontrib>Ito, Shuichi</creatorcontrib><creatorcontrib>Yata, Nahoko</creatorcontrib><creatorcontrib>Ando, Takashi</creatorcontrib><creatorcontrib>Honda, Masataka</creatorcontrib><creatorcontrib>Japanese Study Group of Renal Disease in Children</creatorcontrib><title>Two-Year Follow-Up of a Prospective Clinical Trial of Cyclosporine for Frequently Relapsing Nephrotic Syndrome in Children</title><title>Clinical journal of the American Society of Nephrology</title><addtitle>Clin J Am Soc Nephrol</addtitle><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<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 & 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 & 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 ; Yoshikawa, Norishige ; Nakazato, Hitoshi ; Sasaki, Satoshi ; Iijima, Kazumoto ; Nakanishi, Koichi ; Matsuyama, Takeshi ; Ito, Shuichi ; Yata, Nahoko ; Ando, Takashi ; Honda, Masataka</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c483t-3d8fdd1f6abcba017cd8b7cfcce61f96175d37d75ca5beee24dffb6d42ba75fd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adolescent</topic><topic>Age Factors</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Cyclosporine - administration & dosage</topic><topic>Disease-Free Survival</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Immunosuppressive Agents - administration & dosage</topic><topic>Infant</topic><topic>Infant, Newborn</topic><topic>Japan</topic><topic>Kaplan-Meier Estimate</topic><topic>Male</topic><topic>Nephrotic Syndrome - drug therapy</topic><topic>Nephrotic Syndrome - mortality</topic><topic>Original</topic><topic>Prospective Studies</topic><topic>Recurrence</topic><topic>Risk Factors</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ishikura, Kenji</creatorcontrib><creatorcontrib>Yoshikawa, Norishige</creatorcontrib><creatorcontrib>Nakazato, Hitoshi</creatorcontrib><creatorcontrib>Sasaki, Satoshi</creatorcontrib><creatorcontrib>Iijima, Kazumoto</creatorcontrib><creatorcontrib>Nakanishi, Koichi</creatorcontrib><creatorcontrib>Matsuyama, Takeshi</creatorcontrib><creatorcontrib>Ito, Shuichi</creatorcontrib><creatorcontrib>Yata, Nahoko</creatorcontrib><creatorcontrib>Ando, Takashi</creatorcontrib><creatorcontrib>Honda, Masataka</creatorcontrib><creatorcontrib>Japanese Study Group of Renal Disease in Children</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Clinical journal of the American Society of Nephrology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ishikura, Kenji</au><au>Yoshikawa, Norishige</au><au>Nakazato, Hitoshi</au><au>Sasaki, Satoshi</au><au>Iijima, Kazumoto</au><au>Nakanishi, Koichi</au><au>Matsuyama, Takeshi</au><au>Ito, Shuichi</au><au>Yata, Nahoko</au><au>Ando, Takashi</au><au>Honda, Masataka</au><aucorp>Japanese Study Group of Renal Disease in Children</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Two-Year Follow-Up of a Prospective Clinical Trial of Cyclosporine for Frequently Relapsing Nephrotic Syndrome in Children</atitle><jtitle>Clinical journal of the American Society of Nephrology</jtitle><addtitle>Clin J Am Soc Nephrol</addtitle><date>2012-10-01</date><risdate>2012</risdate><volume>7</volume><issue>10</issue><spage>1576</spage><epage>1583</epage><pages>1576-1583</pages><issn>1555-9041</issn><eissn>1555-905X</eissn><abstract>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<0.001).
Children with FRNS who receive cyclosporine are at high risk of relapse after discontinuation, particularly those who experience relapse during cyclosporine treatment.</abstract><cop>United States</cop><pub>American Society of Nephrology</pub><pmid>22837276</pmid><doi>10.2215/CJN.00110112</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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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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