Evidence map›Paper›PMID 30200895›Full record

Trial reportBMC nephrology2018

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

Taketsugu Hama, Koichi Nakanishi, Kenji Ishikura, Shuichi Ito, Hidefumi Nakamura, Mayumi Sako, Mari Saito-Oba, Kandai Nozu, Yuko Shima, Kazumoto Iijima and 2 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC nephrology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 1 country.

Taketsugu HamaDepartment of Pediatrics, Wakayama Medical University, Wakayama, Japan.
Koichi NakanishiDepartment of Child Health and Welfare (Pediatrics), Graduate School of Medicine, University of the Ryukyus, 207 Uehara, Nishihara, Okinawa, 903-0215, Japan. knakanis@med.u-ryukyu.ac.jp.ORCID 0000-0001-8681-9129
Kenji IshikuraDivision of Nephrology and Rheumatology, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan.
Shuichi ItoDepartment of Pediatrics, Yokohama City University, Yokohama, Kanagawa, Japan.
Hidefumi NakamuraClinical Research Center, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan.
Mayumi SakoDivision of Clinical Trials, Department of Clinical Research Promotion, Clinical Research Center, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan.
Mari Saito-ObaDepartment of Medical Statistics, Toho University School of Medicine, Ota-ku, Tokyo, Japan.
Kandai NozuDepartment of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Hyogo, Japan.
Yuko ShimaDepartment of Pediatrics, Wakayama Medical University, Wakayama, Japan.
Kazumoto IijimaDepartment of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Hyogo, Japan.
Norishige YoshikawaClinical Research Center, Wakayama Medical University, Wakayama, Japan.
Japanese Study Group of Kidney Disease in Children (JSKDC)
Wakayama Medical University · JPNational Center For Child Health and Development · JPToho University · JPUniversity of the Ryukyus · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. DISCUSSION: The 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).

Indexed as

Anti-Inflammatory AgentsAnti-Inflammatory Agents, Non-SteroidalChildChild, PreschoolDose-Response Relationship, DrugDrug Therapy, CombinationFemaleGlucocorticoidsHumansMaleNephrotic SyndromePrednisoloneRecurrenceRibonucleosidesSteroidsAnti-Inflammatory AgentsAnti-Inflammatory Agents, Non-SteroidalGlucocorticoidsmizoribinePrednisoloneRibonucleosidesSteroidsFrequently-relapsing nephrotic syndromeMizoribineSteroid-sensitive nephrotic syndrome

Identifiers

PMID30200895
PMCPMC6131840
OpenAlexW2890230036

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.