Evidence map›Paper›PMID 38010466›Full record

Trial reportClinical and experimental nephrology2024

Rituximab in combination with cyclosporine and steroid pulse therapy for childhood-onset multidrug-resistant nephrotic syndrome: a multicenter single-arm clinical trial (JSKDC11 trial).

Kandai Nozu, Mayumi Sako, Seiji Tanaka, Yuji Kano, Yoko Ohwada, Tamaki Morohashi, Riku Hamada, Yasufumi Ohtsuka, Masafumi Oka, Koichi Kamei and 12 more

Open access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Clinical and experimental nephrology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 24% 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

6 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
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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

22 authors at 14 institutions in 1 country.

Kandai NozuDepartment of Pediatrics, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017, Japan. nozu@med.kobe-u.ac.jp.ORCID http://orcid.org/0000-0002-0290-3137
Mayumi SakoDivision for Clinical Trials, Department of Clinical Research Promotion, Clinical Research Center, National Center for Child Health and Development, Tokyo, Japan.
Seiji TanakaDepartment of Pediatrics, Kurume University School of Medicine, Kurume, Japan.
Yuji KanoDepartment of Pediatrics, Dokkyo Medical University School of Medicine, Tochigi, Japan.
Yoko OhwadaDepartment of Pediatrics, Dokkyo Medical University School of Medicine, Tochigi, Japan.
Tamaki MorohashiDepartment of Pediatrics, Nihon University School of Medicine, Tokyo, Japan.
Riku HamadaDepartment of Nephrology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.
Yasufumi OhtsukaDepartment of Pediatrics, Saga University School of Medicine, Saga, Japan.
Masafumi OkaDepartment of Pediatrics, Saga University School of Medicine, Saga, Japan.
Koichi KameiDivision of Nephrology and Rheumatology, National Center for Child Health and Development, Tokyo, Japan.
Aya InabaDepartment of Pediatrics, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.
Shuichi ItoDepartment of Pediatrics, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.
Tomoyuki SakaiDepartment of Pediatrics, Shiga University of Medical Science, Shiga, Japan.
Hiroshi KaitoDepartment of Nephrology, Hyogo Prefectural Kobe Children's Hospital, Kobe, Japan.
Yuko ShimaDepartment of Pediatrics, Wakayama Medical University, Wakayama, Japan.
Kenji IshikuraDepartment of Pediatrics, Kitasato University School of Medicine, Kanagawa, Japan.
Hidefumi NakamuraClinical Research Center, National Center for Child Health and Development, Tokyo, Japan.
Koichi NakanishiDepartment of Child Health and Welfare (Pediatrics), Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan.
Tomoko HorinouchiDepartment of Pediatrics, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017, Japan.
Akihide KonishiClinical and Translational Research Center, Kobe University Hospital, Kobe, Japan.
Takashi OmoriClinical and Translational Research Center, Kobe University Hospital, Kobe, Japan.
Kazumoto IijimaDepartment of Pediatrics, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017, Japan.
Kobe University · JPNational Center For Child Health and Development · JPDokkyo Medical University · JPKobe University Hospital · JPSaga University · JPYokohama City University · JPKitasato University · JPKobe Children's Hospital · JPKurume University · JPNihon University · JPShiga University of Medical Science · JPTokyo Metropolitan Children's Medical Center · JPUniversity of the Ryukyus · JPWakayama Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOnly 80% of children with idiopathic nephrotic syndrome respond well to glucocorticoid therapy. Multidrug-resistant nephrotic syndrome (MRNS) is associated with a poor kidney prognosis. Several retrospective studies have identified rituximab as an effective treatment for MRNS; however, prospective studies are required to assess its efficacy and safety.

methodsWe conducted a multicenter, non-blinded, single-arm trial to investigate the efficacy and safety of rituximab in patients with childhood-onset MRNS who were resistant to cyclosporine and more than three courses of steroid pulse therapy. The enrolled patients received four 375 mg/m

resultsSix patients with childhood-onset MRNS were enrolled. All patients were negative for pathogenic variants of podocyte-related genes. On day 169, five patients (83.3%) showed a > 50% reduction in the urinary protein/creatinine ratio, two patients showed partial remission, and two patients showed complete remission. No deaths occurred and severe adverse events occurred in two patients (infection in one patient and acute kidney injury in one patient). Three patients needed treatment for moderate-to-severe infection.

conclusionsThe study treatment effectively reduced the urinary protein/creatinine ratio in patients with childhood-onset MRNS. The adverse events in this study were within the expected range; however, attention should be paid to the occurrence of infections.

Indexed as

CyclosporineNephrotic SyndromeChildCreatinineHumansImmunosuppressive AgentsRemission InductionRetrospective StudiesRituximabSteroidsTreatment OutcomeCreatinineCyclosporineImmunosuppressive AgentsRituximabSteroidsCyclosporineMethylprednisoloneMRNSRituximabSRNS

Identifiers

PMID38010466
PMCPMC10955017
OpenAlexW4389050294

What OpenQuestion holds

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LicenceCC BY
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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.