Evidence map›Paper›PMID 25054775›Full record

Trial reportKidney international2015

A multicenter randomized trial indicates initial prednisolone treatment for childhood nephrotic syndrome for two months is not inferior to six-month treatment.

Norishige Yoshikawa, Koichi Nakanishi, Mayumi Sako, Mari S Oba, Rintaro Mori, Erika Ota, Kenji Ishikura, Hiroshi Hataya, Masataka Honda, Shuichi Ito and 8 more

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Kidney international, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03878914 (A Multinational Prospective Study on the Duration of Steroid Therapy in Steroid Sensitive Nephrotic Syndrome), which is not on this map. Cited by 56 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 6 pooled it
6.0field-weighted citation impact, top 3% 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.

NCT03878914 phase4terminatednot on this mapstarted 2019, after this paper: background citation

A Multinational Prospective Study on the Duration of Steroid Therapy in Steroid Sensitive Nephrotic Syndrome

TypeinterventionalSponsorWayne State UniversityRan2019 to 2021Enrolled34ConditionsNephrotic Syndrome in ChildrenArmsCorticosteroids
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 6 syntheses or guidelines pooled it, 131 citations in OpenAlex.

  1. Corticosteroid therapy for nephrotic syndrome in children.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Guideline
  3. Pooled it
  4. Corticosteroid therapy for nephrotic syndrome in children.The Cochrane database of systematic reviews · 2020
    Pooled it
  5. Pooled it
  6. Corticosteroid therapy for nephrotic syndrome in children.The Cochrane database of systematic reviews · 2015
    Pooled it
  7. Trial
  8. Trial
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  11. Trial
  12. Trial
  13. Article
  14. Observational
  15. Article
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  17. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 6 institutions in 1 country.

Norishige YoshikawaDepartment of Pediatrics, Wakayama Medical University, Wakayama City, Japan.
Koichi NakanishiDepartment of Pediatrics, Wakayama Medical University, Wakayama City, Japan.
Mayumi SakoDivision for Clinical Trials, Clinical Research Center, National Center for Child Health and Development, Tokyo, Japan.
Mari S ObaDepartment of Biostatistics and Epidemiology, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.
Rintaro MoriDepartment of Health Policy, National Center for Child Health and Development, Tokyo, Japan.
Erika OtaDepartment of Health Policy, National Center for Child Health and Development, Tokyo, Japan.
Kenji IshikuraDepartment of Nephrology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.
Hiroshi HatayaDepartment of Nephrology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.
Masataka HondaDepartment of Nephrology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.
Shuichi ItoDepartment of Nephrology and Rheumatology, National Center for Child Health and Development, Tokyo, Japan.
Yuko ShimaDepartment of Pediatrics, Wakayama Medical University, Wakayama City, Japan.
Hiroshi KaitoDepartment of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan.
Kandai NozuDepartment of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan.
Hidefumi NakamuraDivision for Clinical Trials, Clinical Research Center, National Center for Child Health and Development, Tokyo, Japan.
Takashi IgarashiNational Center for Child Health and Development, Tokyo, Japan.
Yasuo OhashiDepartment of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan.
Kazumoto IijimaDepartment of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan.
Japanese Study Group of Kidney Disease in Children
National Center For Child Health and Development · JPKobe University · JPTokyo Metropolitan Children's Medical Center · JPWakayama Medical University · JPThe University of Tokyo · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this multicenter, open-label, randomized controlled trial, we determined whether 2-month prednisolone therapy for steroid-sensitive nephrotic syndrome was inferior or not to 6-month therapy despite significantly less steroid exposure. The primary end point was time from start of initial treatment to start of frequently relapsing nephrotic syndrome. The pre-specified non-inferiority margin was a hazard ratio of 1.3 with one-sided significance of 5%. We randomly assigned 255 children with an initial episode of steroid-sensitive nephrotic syndrome to either 2 - or 6-month treatment of which 246 were eligible for final analysis. The total prednisolone exposure counted both initial and relapse prednisolone treatment administered over 24 months. Median follow-up in months was 36.7 in the 2-month and 38.2 in the 6-month treatment group. Time to frequent relaps was similar in both groups; however, the median was reached only in the 6-month group (799 days). The hazard ratio was 0.86 (90% confidence interval, 0.64-1.16) and met the non-inferior margin. Time to first relapse was also similar in both groups: median day 242 (2-month) and 243 (6-month). Frequency and severity of adverse events were similar in both groups. Most adverse events were transient and occurred during initial or relapse therapy. Thus, 2 months of initial prednisolone therapy for steroid-sensitive nephrotic syndrome, despite less prednisolone exposure, is not inferior to 6 months of initial therapy in terms of time to onset of frequently relapsing nephrotic syndrome.

Indexed as

AdolescentChildChild, PreschoolFemaleGlucocorticoidsHumansInfantMaleNephrotic SyndromePrednisoloneRecurrenceGlucocorticoidsPrednisolone

Identifiers

PMID25054775
PMCPMC4284810
OpenAlexW2168584903

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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.