Study protocol: high-dose mizoribine with prednisolone therapy in short-term relapsing steroid-sensitive nephrotic syndrome to prevent frequent relapse (JSKDC05 trial) View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2018-09-10

AUTHORS

Taketsugu Hama, Koichi Nakanishi, Kenji Ishikura, Shuichi Ito, Hidefumi Nakamura, Mayumi Sako, Mari Saito-Oba, Kandai Nozu, Yuko Shima, Kazumoto Iijima, Norishige Yoshikawa, for the Japanese Study Group of Kidney Disease in Children (JSKDC)

ABSTRACT

BackgroundEighty percent of children with steroid-sensitive nephrotic syndrome (SSNS) relapse within 2 years and 40–50% patients show frequently-relapsing nephrotic syndrome (FRNS). Patients showing a relapse within 6 months after initial remission are at high risk of FRNS. Since frequent prednisolone treatment for FRNS induces severe prednisolone side effects, development of a treatment to prevent patients from shifting to FRNS is desirable. Mizoribine is an immunosuppressive drug with fewer side effects than prednisolone. Recent studies reported the efficacy of high-dose mizoribine in children with FRNS.Methods/designWe conduct a multicenter, open, randomized controlled trial to investigate the efficacy and safety of standard prednisolone plus high-dose mizoribine therapy in children with SSNS showing a relapse within 6 months after an initial remission. Patients are allocated to either standard prednisolone alone treatment group, or standard prednisolone plus high-dose mizoribine group. For the former group, mizoribine is administered at a dose of 10 mg/kg/day once daily and continued for 2 years. The primary endpoint is the duration to frequent relapse.DiscussionThe results provide important data on use of high-dose mizoribine to prevent SSNS patients from shifting to FRNS. Since blood concentrations of mizoribine have not been investigated in detail until now, there is a possibility that mizoribine is underestimated in favor of other immunosuppressive drugs. In future, high-dose mizoribine therapy may lead to prevention of relapse in children at high risk of FRNS, and to decreased total dose of prednisolone.Trial registrationUMIN000005103, (Prospectively registered 1st March 2011). More... »

PAGES

223

Journal

TITLE

BMC Nephrology

ISSUE

1

VOLUME

19

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s12882-018-1033-z

DOI

http://dx.doi.org/10.1186/s12882-018-1033-z

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1106910050

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30200895


Indexing Status Check whether this publication has been indexed by Scopus and Web Of Science using the SN Indexing Status Tool
Incoming Citations Browse incoming citations for this publication using opencitations.net

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/11", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Medical and Health Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1103", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Clinical Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Anti-Inflammatory Agents", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Anti-Inflammatory Agents, Non-Steroidal", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Child", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Child, Preschool", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Dose-Response Relationship, Drug", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Drug Therapy, Combination", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Female", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Glucocorticoids", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Humans", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Male", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Nephrotic Syndrome", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Prednisolone", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Recurrence", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Ribonucleosides", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Steroids", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "Department of Pediatrics, Wakayama Medical University, Wakayama, Japan", 
          "id": "http://www.grid.ac/institutes/grid.412857.d", 
          "name": [
            "Department of Pediatrics, Wakayama Medical University, Wakayama, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Hama", 
        "givenName": "Taketsugu", 
        "id": "sg:person.01325413345.54", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01325413345.54"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Child Health and Welfare (Pediatrics), Graduate School of Medicine, University of the Ryukyus, 207 Uehara, 903-0215, Nishihara, Okinawa, Japan", 
          "id": "http://www.grid.ac/institutes/grid.267625.2", 
          "name": [
            "Department of Child Health and Welfare (Pediatrics), Graduate School of Medicine, University of the Ryukyus, 207 Uehara, 903-0215, Nishihara, Okinawa, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Nakanishi", 
        "givenName": "Koichi", 
        "id": "sg:person.0611445101.47", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0611445101.47"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Division of Nephrology and Rheumatology, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan", 
          "id": "http://www.grid.ac/institutes/grid.63906.3a", 
          "name": [
            "Division of Nephrology and Rheumatology, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Ishikura", 
        "givenName": "Kenji", 
        "id": "sg:person.01112735663.13", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01112735663.13"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Pediatrics, Yokohama City University, Yokohama, Kanagawa, Japan", 
          "id": "http://www.grid.ac/institutes/grid.268441.d", 
          "name": [
            "Department of Pediatrics, Yokohama City University, Yokohama, Kanagawa, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Ito", 
        "givenName": "Shuichi", 
        "id": "sg:person.012302533312.63", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.012302533312.63"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Clinical Research Center, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan", 
          "id": "http://www.grid.ac/institutes/grid.63906.3a", 
          "name": [
            "Clinical Research Center, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Nakamura", 
        "givenName": "Hidefumi", 
        "id": "sg:person.016521443562.02", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.016521443562.02"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Division of Clinical Trials, Department of Clinical Research Promotion, Clinical Research Center, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan", 
          "id": "http://www.grid.ac/institutes/grid.63906.3a", 
          "name": [
            "Division of Clinical Trials, Department of Clinical Research Promotion, Clinical Research Center, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Sako", 
        "givenName": "Mayumi", 
        "id": "sg:person.01032464245.22", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01032464245.22"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Medical Statistics, Toho University School of Medicine, Ota-ku, Tokyo, Japan", 
          "id": "http://www.grid.ac/institutes/grid.265050.4", 
          "name": [
            "Department of Medical Statistics, Toho University School of Medicine, Ota-ku, Tokyo, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Saito-Oba", 
        "givenName": "Mari", 
        "id": "sg:person.015476764640.15", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.015476764640.15"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Hyogo, Japan", 
          "id": "http://www.grid.ac/institutes/grid.31432.37", 
          "name": [
            "Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Hyogo, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Nozu", 
        "givenName": "Kandai", 
        "id": "sg:person.0717317506.56", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0717317506.56"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Pediatrics, Wakayama Medical University, Wakayama, Japan", 
          "id": "http://www.grid.ac/institutes/grid.412857.d", 
          "name": [
            "Department of Pediatrics, Wakayama Medical University, Wakayama, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Shima", 
        "givenName": "Yuko", 
        "id": "sg:person.01211164745.63", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01211164745.63"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Hyogo, Japan", 
          "id": "http://www.grid.ac/institutes/grid.31432.37", 
          "name": [
            "Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Hyogo, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Iijima", 
        "givenName": "Kazumoto", 
        "id": "sg:person.01360637141.54", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01360637141.54"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Clinical Research Center, Wakayama Medical University, Wakayama, Japan", 
          "id": "http://www.grid.ac/institutes/grid.412857.d", 
          "name": [
            "Clinical Research Center, Wakayama Medical University, Wakayama, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Yoshikawa", 
        "givenName": "Norishige", 
        "id": "sg:person.0751461441.06", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0751461441.06"
        ], 
        "type": "Person"
      }, 
      {
        "familyName": "for the Japanese Study Group of Kidney Disease in Children (JSKDC)", 
        "id": "sg:person.07417547447.35", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.07417547447.35"
        ], 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "sg:pub.10.1007/s00467-006-0120-8", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1026836493", 
          "https://doi.org/10.1007/s00467-006-0120-8"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s10165-007-0567-x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1008314861", 
          "https://doi.org/10.1007/s10165-007-0567-x"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/bf00866378", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1001611195", 
          "https://doi.org/10.1007/bf00866378"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s10157-016-1353-x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1024780394", 
          "https://doi.org/10.1007/s10157-016-1353-x"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s10157-015-1209-9", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1016483623", 
          "https://doi.org/10.1007/s10157-015-1209-9"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s00467-005-2025-3", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1001942163", 
          "https://doi.org/10.1007/s00467-005-2025-3"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s10157-010-0356-2", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1026231836", 
          "https://doi.org/10.1007/s10157-010-0356-2"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s00467-007-0731-8", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1015912803", 
          "https://doi.org/10.1007/s00467-007-0731-8"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "2018-09-10", 
    "datePublishedReg": "2018-09-10", 
    "description": "BackgroundEighty percent of children with steroid-sensitive nephrotic syndrome (SSNS) relapse within 2\u00a0years and 40\u201350% patients show frequently-relapsing nephrotic syndrome (FRNS). Patients showing a relapse within 6\u00a0months after initial remission are at high risk of FRNS. Since frequent prednisolone treatment for FRNS induces severe prednisolone side effects, development of a treatment to prevent patients from shifting to FRNS is desirable. Mizoribine is an immunosuppressive drug with fewer side effects than prednisolone. Recent studies reported the efficacy of high-dose mizoribine in children with FRNS.Methods/designWe conduct a multicenter, open, randomized controlled trial to investigate the efficacy and safety of standard prednisolone plus high-dose mizoribine therapy in children with SSNS showing a relapse within 6\u00a0months after an initial remission. Patients are allocated to either standard prednisolone alone treatment group, or standard prednisolone plus high-dose mizoribine group. For the former group, mizoribine is administered at a dose of 10\u00a0mg/kg/day once daily and continued for 2\u00a0years. The primary endpoint is the duration to frequent relapse.DiscussionThe results provide important data on use of high-dose mizoribine to prevent SSNS patients from shifting to FRNS. Since blood concentrations of mizoribine have not been investigated in detail until now, there is a possibility that mizoribine is underestimated in favor of other immunosuppressive drugs. In future, high-dose mizoribine therapy may lead to prevention of relapse in children at high risk of FRNS, and to decreased total dose of prednisolone.Trial registrationUMIN000005103, (Prospectively registered 1st March 2011).", 
    "genre": "article", 
    "id": "sg:pub.10.1186/s12882-018-1033-z", 
    "inLanguage": "en", 
    "isAccessibleForFree": true, 
    "isFundedItemOf": [
      {
        "id": "sg:grant.5871719", 
        "type": "MonetaryGrant"
      }, 
      {
        "id": "sg:grant.7534629", 
        "type": "MonetaryGrant"
      }, 
      {
        "id": "sg:grant.7853213", 
        "type": "MonetaryGrant"
      }
    ], 
    "isPartOf": [
      {
        "id": "sg:journal.1024626", 
        "issn": [
          "1471-2369"
        ], 
        "name": "BMC Nephrology", 
        "publisher": "Springer Nature", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "1", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "19"
      }
    ], 
    "keywords": [
      "steroid-sensitive nephrotic syndrome", 
      "high-dose mizoribine", 
      "nephrotic syndrome", 
      "mizoribine therapy", 
      "initial remission", 
      "frequent relapses", 
      "immunosuppressive drugs", 
      "high risk", 
      "side effects", 
      "standard prednisolone", 
      "prevention of relapse", 
      "alone treatment group", 
      "mizoribine group", 
      "prednisolone therapy", 
      "primary endpoint", 
      "prednisolone treatment", 
      "SSNS patients", 
      "blood concentrations", 
      "mizoribine", 
      "treatment groups", 
      "relapse", 
      "patients", 
      "prednisolone", 
      "total dose", 
      "FRNS", 
      "syndrome", 
      "therapy", 
      "former group", 
      "remission", 
      "children", 
      "dose", 
      "months", 
      "drugs", 
      "efficacy", 
      "Recent studies", 
      "treatment", 
      "risk", 
      "group", 
      "multicenter", 
      "DesignWe", 
      "years", 
      "trials", 
      "endpoint", 
      "prevention", 
      "duration", 
      "days", 
      "safety", 
      "percent", 
      "effect", 
      "important data", 
      "study", 
      "concentration", 
      "use", 
      "data", 
      "development", 
      "favor", 
      "results", 
      "possibility", 
      "detail"
    ], 
    "name": "Study protocol: high-dose mizoribine with prednisolone therapy in short-term relapsing steroid-sensitive nephrotic syndrome to prevent frequent relapse (JSKDC05 trial)", 
    "pagination": "223", 
    "productId": [
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1106910050"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1186/s12882-018-1033-z"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "30200895"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1186/s12882-018-1033-z", 
      "https://app.dimensions.ai/details/publication/pub.1106910050"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2022-05-10T10:19", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-springernature-scigraph/baseset/20220509/entities/gbq_results/article/article_791.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "https://doi.org/10.1186/s12882-018-1033-z"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1186/s12882-018-1033-z'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1186/s12882-018-1033-z'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1186/s12882-018-1033-z'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1186/s12882-018-1033-z'


 

This table displays all metadata directly associated to this object as RDF triples.

314 TRIPLES      22 PREDICATES      108 URIs      92 LITERALS      22 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1186/s12882-018-1033-z schema:about N0c204f3fef4a43c48523a9c002cb247b
2 N18fa2e47c5a44cb3915d74a31a08ec29
3 N23476272dc0d429aabe4836f8f9e6e62
4 N47293ee11f0546a390022a75b94e5fba
5 N61a6643bc4b145478fe84dea4989adbd
6 N8d03e638ad70474abac78f7e870f338a
7 N935eea9222e144f5b5f14dc1914843da
8 Nbb2b6c5cb0ef46ba8bbae3ece3a77cef
9 Nc62a38edf7a346908934ca4f8db65e8b
10 Nc7477db4d908422da93f3df4de0a32a1
11 Ncac9abb4e33344ef9854129fb53f4562
12 Ne33daa54e8894afd9fbf164b346700e0
13 Ned2a210adc7c4e12861d9a650dd416de
14 Nf29e643e3b464fbb91dab4f346de8a40
15 Nfd167441c8bf43b08137159d8a0d6195
16 anzsrc-for:11
17 anzsrc-for:1103
18 schema:author N48c6e919f6244b2e9a3366a60cc99b9a
19 schema:citation sg:pub.10.1007/bf00866378
20 sg:pub.10.1007/s00467-005-2025-3
21 sg:pub.10.1007/s00467-006-0120-8
22 sg:pub.10.1007/s00467-007-0731-8
23 sg:pub.10.1007/s10157-010-0356-2
24 sg:pub.10.1007/s10157-015-1209-9
25 sg:pub.10.1007/s10157-016-1353-x
26 sg:pub.10.1007/s10165-007-0567-x
27 schema:datePublished 2018-09-10
28 schema:datePublishedReg 2018-09-10
29 schema:description BackgroundEighty percent of children with steroid-sensitive nephrotic syndrome (SSNS) relapse within 2 years and 40–50% patients show frequently-relapsing nephrotic syndrome (FRNS). Patients showing a relapse within 6 months after initial remission are at high risk of FRNS. Since frequent prednisolone treatment for FRNS induces severe prednisolone side effects, development of a treatment to prevent patients from shifting to FRNS is desirable. Mizoribine is an immunosuppressive drug with fewer side effects than prednisolone. Recent studies reported the efficacy of high-dose mizoribine in children with FRNS.Methods/designWe conduct a multicenter, open, randomized controlled trial to investigate the efficacy and safety of standard prednisolone plus high-dose mizoribine therapy in children with SSNS showing a relapse within 6 months after an initial remission. Patients are allocated to either standard prednisolone alone treatment group, or standard prednisolone plus high-dose mizoribine group. For the former group, mizoribine is administered at a dose of 10 mg/kg/day once daily and continued for 2 years. The primary endpoint is the duration to frequent relapse.DiscussionThe results provide important data on use of high-dose mizoribine to prevent SSNS patients from shifting to FRNS. Since blood concentrations of mizoribine have not been investigated in detail until now, there is a possibility that mizoribine is underestimated in favor of other immunosuppressive drugs. In future, high-dose mizoribine therapy may lead to prevention of relapse in children at high risk of FRNS, and to decreased total dose of prednisolone.Trial registrationUMIN000005103, (Prospectively registered 1st March 2011).
30 schema:genre article
31 schema:inLanguage en
32 schema:isAccessibleForFree true
33 schema:isPartOf N0fbad749ae5243ccb112fc3b8bbb98e7
34 N94d1babb13a7490b8d3fc5eed0d24c92
35 sg:journal.1024626
36 schema:keywords DesignWe
37 FRNS
38 Recent studies
39 SSNS patients
40 alone treatment group
41 blood concentrations
42 children
43 concentration
44 data
45 days
46 detail
47 development
48 dose
49 drugs
50 duration
51 effect
52 efficacy
53 endpoint
54 favor
55 former group
56 frequent relapses
57 group
58 high risk
59 high-dose mizoribine
60 immunosuppressive drugs
61 important data
62 initial remission
63 mizoribine
64 mizoribine group
65 mizoribine therapy
66 months
67 multicenter
68 nephrotic syndrome
69 patients
70 percent
71 possibility
72 prednisolone
73 prednisolone therapy
74 prednisolone treatment
75 prevention
76 prevention of relapse
77 primary endpoint
78 relapse
79 remission
80 results
81 risk
82 safety
83 side effects
84 standard prednisolone
85 steroid-sensitive nephrotic syndrome
86 study
87 syndrome
88 therapy
89 total dose
90 treatment
91 treatment groups
92 trials
93 use
94 years
95 schema:name Study protocol: high-dose mizoribine with prednisolone therapy in short-term relapsing steroid-sensitive nephrotic syndrome to prevent frequent relapse (JSKDC05 trial)
96 schema:pagination 223
97 schema:productId N94450b243b3649acb37baa45fc660f23
98 Na75dbe75291941d18409657f78cc7323
99 Nc5c9ea883d55473d9b5d07bccaa8f34a
100 schema:sameAs https://app.dimensions.ai/details/publication/pub.1106910050
101 https://doi.org/10.1186/s12882-018-1033-z
102 schema:sdDatePublished 2022-05-10T10:19
103 schema:sdLicense https://scigraph.springernature.com/explorer/license/
104 schema:sdPublisher N88e8431482884af9ae6ed108a7b767d5
105 schema:url https://doi.org/10.1186/s12882-018-1033-z
106 sgo:license sg:explorer/license/
107 sgo:sdDataset articles
108 rdf:type schema:ScholarlyArticle
109 N0c204f3fef4a43c48523a9c002cb247b schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
110 schema:name Anti-Inflammatory Agents, Non-Steroidal
111 rdf:type schema:DefinedTerm
112 N0fbad749ae5243ccb112fc3b8bbb98e7 schema:issueNumber 1
113 rdf:type schema:PublicationIssue
114 N18fa2e47c5a44cb3915d74a31a08ec29 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
115 schema:name Ribonucleosides
116 rdf:type schema:DefinedTerm
117 N23476272dc0d429aabe4836f8f9e6e62 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
118 schema:name Prednisolone
119 rdf:type schema:DefinedTerm
120 N27f0ed789f1c4d9f8fc1dbe8b9f36734 rdf:first sg:person.016521443562.02
121 rdf:rest Nde3c225a16d64d6b947f2aba150f752c
122 N35e7aa03cf2f4a3c851a4ba03ee41545 rdf:first sg:person.07417547447.35
123 rdf:rest rdf:nil
124 N41b383f86e5d415e8987d5223764fed6 rdf:first sg:person.01112735663.13
125 rdf:rest N65d2a432f11f4ad8b33c29d5dd5b1874
126 N47293ee11f0546a390022a75b94e5fba schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
127 schema:name Child, Preschool
128 rdf:type schema:DefinedTerm
129 N48c6e919f6244b2e9a3366a60cc99b9a rdf:first sg:person.01325413345.54
130 rdf:rest N905a179bbd7648918dab13edecd334e1
131 N615e3c9110324a80942b6b444793e597 rdf:first sg:person.015476764640.15
132 rdf:rest Nb0843dd7cdb54906a4121bf36dfafae3
133 N61a6643bc4b145478fe84dea4989adbd schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
134 schema:name Humans
135 rdf:type schema:DefinedTerm
136 N65d2a432f11f4ad8b33c29d5dd5b1874 rdf:first sg:person.012302533312.63
137 rdf:rest N27f0ed789f1c4d9f8fc1dbe8b9f36734
138 N88e8431482884af9ae6ed108a7b767d5 schema:name Springer Nature - SN SciGraph project
139 rdf:type schema:Organization
140 N8d03e638ad70474abac78f7e870f338a schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
141 schema:name Recurrence
142 rdf:type schema:DefinedTerm
143 N905a179bbd7648918dab13edecd334e1 rdf:first sg:person.0611445101.47
144 rdf:rest N41b383f86e5d415e8987d5223764fed6
145 N935eea9222e144f5b5f14dc1914843da schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
146 schema:name Drug Therapy, Combination
147 rdf:type schema:DefinedTerm
148 N94450b243b3649acb37baa45fc660f23 schema:name dimensions_id
149 schema:value pub.1106910050
150 rdf:type schema:PropertyValue
151 N94d1babb13a7490b8d3fc5eed0d24c92 schema:volumeNumber 19
152 rdf:type schema:PublicationVolume
153 N987f038f759c41178611fc6b046a2395 rdf:first sg:person.0751461441.06
154 rdf:rest N35e7aa03cf2f4a3c851a4ba03ee41545
155 Na75dbe75291941d18409657f78cc7323 schema:name doi
156 schema:value 10.1186/s12882-018-1033-z
157 rdf:type schema:PropertyValue
158 Nadd610b7ae2a482482e365874065e106 rdf:first sg:person.01360637141.54
159 rdf:rest N987f038f759c41178611fc6b046a2395
160 Nb0843dd7cdb54906a4121bf36dfafae3 rdf:first sg:person.0717317506.56
161 rdf:rest Nc4874b5a2dad4fecbeebc04b294d52f5
162 Nbb2b6c5cb0ef46ba8bbae3ece3a77cef schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
163 schema:name Glucocorticoids
164 rdf:type schema:DefinedTerm
165 Nc4874b5a2dad4fecbeebc04b294d52f5 rdf:first sg:person.01211164745.63
166 rdf:rest Nadd610b7ae2a482482e365874065e106
167 Nc5c9ea883d55473d9b5d07bccaa8f34a schema:name pubmed_id
168 schema:value 30200895
169 rdf:type schema:PropertyValue
170 Nc62a38edf7a346908934ca4f8db65e8b schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
171 schema:name Steroids
172 rdf:type schema:DefinedTerm
173 Nc7477db4d908422da93f3df4de0a32a1 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
174 schema:name Anti-Inflammatory Agents
175 rdf:type schema:DefinedTerm
176 Ncac9abb4e33344ef9854129fb53f4562 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
177 schema:name Dose-Response Relationship, Drug
178 rdf:type schema:DefinedTerm
179 Nde3c225a16d64d6b947f2aba150f752c rdf:first sg:person.01032464245.22
180 rdf:rest N615e3c9110324a80942b6b444793e597
181 Ne33daa54e8894afd9fbf164b346700e0 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
182 schema:name Female
183 rdf:type schema:DefinedTerm
184 Ned2a210adc7c4e12861d9a650dd416de schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
185 schema:name Child
186 rdf:type schema:DefinedTerm
187 Nf29e643e3b464fbb91dab4f346de8a40 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
188 schema:name Nephrotic Syndrome
189 rdf:type schema:DefinedTerm
190 Nfd167441c8bf43b08137159d8a0d6195 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
191 schema:name Male
192 rdf:type schema:DefinedTerm
193 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
194 schema:name Medical and Health Sciences
195 rdf:type schema:DefinedTerm
196 anzsrc-for:1103 schema:inDefinedTermSet anzsrc-for:
197 schema:name Clinical Sciences
198 rdf:type schema:DefinedTerm
199 sg:grant.5871719 http://pending.schema.org/fundedItem sg:pub.10.1186/s12882-018-1033-z
200 rdf:type schema:MonetaryGrant
201 sg:grant.7534629 http://pending.schema.org/fundedItem sg:pub.10.1186/s12882-018-1033-z
202 rdf:type schema:MonetaryGrant
203 sg:grant.7853213 http://pending.schema.org/fundedItem sg:pub.10.1186/s12882-018-1033-z
204 rdf:type schema:MonetaryGrant
205 sg:journal.1024626 schema:issn 1471-2369
206 schema:name BMC Nephrology
207 schema:publisher Springer Nature
208 rdf:type schema:Periodical
209 sg:person.01032464245.22 schema:affiliation grid-institutes:grid.63906.3a
210 schema:familyName Sako
211 schema:givenName Mayumi
212 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01032464245.22
213 rdf:type schema:Person
214 sg:person.01112735663.13 schema:affiliation grid-institutes:grid.63906.3a
215 schema:familyName Ishikura
216 schema:givenName Kenji
217 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01112735663.13
218 rdf:type schema:Person
219 sg:person.01211164745.63 schema:affiliation grid-institutes:grid.412857.d
220 schema:familyName Shima
221 schema:givenName Yuko
222 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01211164745.63
223 rdf:type schema:Person
224 sg:person.012302533312.63 schema:affiliation grid-institutes:grid.268441.d
225 schema:familyName Ito
226 schema:givenName Shuichi
227 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.012302533312.63
228 rdf:type schema:Person
229 sg:person.01325413345.54 schema:affiliation grid-institutes:grid.412857.d
230 schema:familyName Hama
231 schema:givenName Taketsugu
232 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01325413345.54
233 rdf:type schema:Person
234 sg:person.01360637141.54 schema:affiliation grid-institutes:grid.31432.37
235 schema:familyName Iijima
236 schema:givenName Kazumoto
237 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01360637141.54
238 rdf:type schema:Person
239 sg:person.015476764640.15 schema:affiliation grid-institutes:grid.265050.4
240 schema:familyName Saito-Oba
241 schema:givenName Mari
242 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.015476764640.15
243 rdf:type schema:Person
244 sg:person.016521443562.02 schema:affiliation grid-institutes:grid.63906.3a
245 schema:familyName Nakamura
246 schema:givenName Hidefumi
247 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.016521443562.02
248 rdf:type schema:Person
249 sg:person.0611445101.47 schema:affiliation grid-institutes:grid.267625.2
250 schema:familyName Nakanishi
251 schema:givenName Koichi
252 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0611445101.47
253 rdf:type schema:Person
254 sg:person.0717317506.56 schema:affiliation grid-institutes:grid.31432.37
255 schema:familyName Nozu
256 schema:givenName Kandai
257 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0717317506.56
258 rdf:type schema:Person
259 sg:person.07417547447.35 schema:familyName for the Japanese Study Group of Kidney Disease in Children (JSKDC)
260 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.07417547447.35
261 rdf:type schema:Person
262 sg:person.0751461441.06 schema:affiliation grid-institutes:grid.412857.d
263 schema:familyName Yoshikawa
264 schema:givenName Norishige
265 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0751461441.06
266 rdf:type schema:Person
267 sg:pub.10.1007/bf00866378 schema:sameAs https://app.dimensions.ai/details/publication/pub.1001611195
268 https://doi.org/10.1007/bf00866378
269 rdf:type schema:CreativeWork
270 sg:pub.10.1007/s00467-005-2025-3 schema:sameAs https://app.dimensions.ai/details/publication/pub.1001942163
271 https://doi.org/10.1007/s00467-005-2025-3
272 rdf:type schema:CreativeWork
273 sg:pub.10.1007/s00467-006-0120-8 schema:sameAs https://app.dimensions.ai/details/publication/pub.1026836493
274 https://doi.org/10.1007/s00467-006-0120-8
275 rdf:type schema:CreativeWork
276 sg:pub.10.1007/s00467-007-0731-8 schema:sameAs https://app.dimensions.ai/details/publication/pub.1015912803
277 https://doi.org/10.1007/s00467-007-0731-8
278 rdf:type schema:CreativeWork
279 sg:pub.10.1007/s10157-010-0356-2 schema:sameAs https://app.dimensions.ai/details/publication/pub.1026231836
280 https://doi.org/10.1007/s10157-010-0356-2
281 rdf:type schema:CreativeWork
282 sg:pub.10.1007/s10157-015-1209-9 schema:sameAs https://app.dimensions.ai/details/publication/pub.1016483623
283 https://doi.org/10.1007/s10157-015-1209-9
284 rdf:type schema:CreativeWork
285 sg:pub.10.1007/s10157-016-1353-x schema:sameAs https://app.dimensions.ai/details/publication/pub.1024780394
286 https://doi.org/10.1007/s10157-016-1353-x
287 rdf:type schema:CreativeWork
288 sg:pub.10.1007/s10165-007-0567-x schema:sameAs https://app.dimensions.ai/details/publication/pub.1008314861
289 https://doi.org/10.1007/s10165-007-0567-x
290 rdf:type schema:CreativeWork
291 grid-institutes:grid.265050.4 schema:alternateName Department of Medical Statistics, Toho University School of Medicine, Ota-ku, Tokyo, Japan
292 schema:name Department of Medical Statistics, Toho University School of Medicine, Ota-ku, Tokyo, Japan
293 rdf:type schema:Organization
294 grid-institutes:grid.267625.2 schema:alternateName Department of Child Health and Welfare (Pediatrics), Graduate School of Medicine, University of the Ryukyus, 207 Uehara, 903-0215, Nishihara, Okinawa, Japan
295 schema:name Department of Child Health and Welfare (Pediatrics), Graduate School of Medicine, University of the Ryukyus, 207 Uehara, 903-0215, Nishihara, Okinawa, Japan
296 rdf:type schema:Organization
297 grid-institutes:grid.268441.d schema:alternateName Department of Pediatrics, Yokohama City University, Yokohama, Kanagawa, Japan
298 schema:name Department of Pediatrics, Yokohama City University, Yokohama, Kanagawa, Japan
299 rdf:type schema:Organization
300 grid-institutes:grid.31432.37 schema:alternateName Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Hyogo, Japan
301 schema:name Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Hyogo, Japan
302 rdf:type schema:Organization
303 grid-institutes:grid.412857.d schema:alternateName Clinical Research Center, Wakayama Medical University, Wakayama, Japan
304 Department of Pediatrics, Wakayama Medical University, Wakayama, Japan
305 schema:name Clinical Research Center, Wakayama Medical University, Wakayama, Japan
306 Department of Pediatrics, Wakayama Medical University, Wakayama, Japan
307 rdf:type schema:Organization
308 grid-institutes:grid.63906.3a schema:alternateName Clinical Research Center, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan
309 Division of Clinical Trials, Department of Clinical Research Promotion, Clinical Research Center, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan
310 Division of Nephrology and Rheumatology, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan
311 schema:name Clinical Research Center, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan
312 Division of Clinical Trials, Department of Clinical Research Promotion, Clinical Research Center, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan
313 Division of Nephrology and Rheumatology, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan
314 rdf:type schema:Organization
 




Preview window. Press ESC to close (or click here)


...