Evidence map›Paper›PMID 28664242›Full record

Trial reportPediatric nephrology (Berlin, Germany)2017

Long-term outcome of childhood-onset complicated nephrotic syndrome after a multicenter, double-blind, randomized, placebo-controlled trial of rituximab.

Koichi Kamei, Kenji Ishikura, Mayumi Sako, Kunihiko Aya, Ryojiro Tanaka, Kandai Nozu, Hiroshi Kaito, Koichi Nakanishi, Yoshiyuki Ohtomo, Kenichiro Miura and 7 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Pediatric nephrology (Berlin, Germany), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 pooled it
3.7field-weighted citation impact, top 6% 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

33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 53 citations in OpenAlex.

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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

17 authors at 8 institutions in 1 country.

Koichi KameiDivision of Nephrology and Rheumatology, National Center for Child Health and Development, 2-10-1, Okura, Setagaya-ku, Tokyo, 157-8535, Japan. kamei-k@ncchd.go.jp.
Kenji IshikuraDivision of Nephrology and Rheumatology, National Center for Child Health and Development, 2-10-1, Okura, Setagaya-ku, Tokyo, 157-8535, Japan.
Mayumi SakoDivision for Clinical Trials, Department of Clinical Research, Center for Clinical Research and Development, National Center for Child Health and Development, 2-10-1, Okura, Setagaya-ku, Tokyo, 157-8535, Japan.
Kunihiko AyaDepartment of Pediatrics, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, 710-8602, Japan.
Ryojiro TanakaDepartment of Nephrology, Hyogo Prefectural Kobe Children's Hospital, 1-6-7, Minamimachi, Minatojima, Chuo-ku, Kobe, Hyogo, 650-0047, Japan.
Kandai NozuDepartment of Pediatrics, Kobe University Graduate School of Medicine, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.
Hiroshi KaitoDepartment of Pediatrics, Kobe University Graduate School of Medicine, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.
Koichi NakanishiDepartment of Child Health and Welfare (Pediatrics), Graduate School of Medicine, University of the Ryukyus, 207, Azauehara, Nishihara-cho, Nakagami-gun, Okinawa, 903-0215, Japan.
Yoshiyuki OhtomoDepartment of Pediatrics, Juntendo University Nerima Hospital, 3-1-10, Takanodai, Nerima-ku, Tokyo, 177-8521, Japan.
Kenichiro MiuraDepartment of Pediatric Nephrology, Tokyo Women's Medical University, School of Medicine, 8-1, Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.
Shori TakahashiDepartment of Pediatrics, Nihon University Itabashi Hospital, 30-1, Oyaguchikamimachi, Itabashi-ku, Tokyo, 173-8610, Japan.
Tetsuji MorimotoDivision of Pediatrics, Tohoku Medical and Pharmaceutical University Hospital, 1-12-1, Fukumuro, Miyagino-ku, Sendai, Miyagi, 983-8512, Japan.
Wataru KubotaDepartment of Nephrology, Tokyo Metropolitan Children's Medical Center, 2-8-29, Musashidai, Fuchu, Tokyo, 183-8561, Japan.
Shuichi ItoDepartment of Pediatrics, Graduate School of Medicine, Yokohama City University, 3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan.
Hidefumi NakamuraDepartment of Development Strategy, Center for Clinical Research and Development, National Center for Child Health and Development, 2-10-1, Okura, Setagaya-ku, Tokyo, 157-8535, Japan.
Kazumoto IijimaDepartment of Pediatrics, Kobe University Graduate School of Medicine, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.
Rituximab for Childhood-Onset Refractory Nephrotic Syndrome (RCRNS) Study Group
National Center For Child Health and Development · JPKobe University · JPKurashiki Central Hospital · JPTohoku Medical and Pharmaceutical University Hospital · JPTokyo Women's Medical University · JPUniversity of the Ryukyus · JPKobe Children's Hospital · JPTokyo Metropolitan Children's Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough rituximab effectively prevents relapses of complicated frequently relapsing nephrotic syndrome (FRNS) and steroid-dependent nephrotic syndrome (SDNS), data of long-term outcomes and safety are limited.

methodsFifty-one patients (age, 3-38 years) with childhood-onset complicated FRNS or SDNS, who received rituximab in investigator-initiated multicenter prospective trials were enrolled. Rituximab was administered at 375 mg/m

resultsForty-eight patients (94%) developed relapses during the observation period (median, 59 months) and the 50% relapse-free survival was 261 days. Thirty patients (59%) developed SDNS, 44 (86%) required re-administration of immunosuppressive agents, and 22 (43%) received additional rituximab treatment. All patients who were receiving immunosuppressive agents at rituximab treatment required either immunosuppressive agents or additional rituximab treatment. On the contrary, 5 of the 13 patients without immunosuppressive agents at rituximab treatment required neither immunosuppressive agents nor additional rituximab treatment and 3 of them did not develop relapse during observation period. Growth failure due to steroid toxicity did not progress and none of the patients developed chronic renal insufficiency. None of the patients suffered from rituximab-related late adverse events.

conclusionsAs most patients suffer from relapses after B-cell recovery, long-term immunosuppressive agents or additional rituximab treatment is necessary. However, some patients who can discontinue immunosuppressive agents before rituximab treatment may achieve long-term remission after rituximab treatment without immunosuppressive agents.

Indexed as

Immunologic FactorsNephrotic SyndromeRituximabAdolescentAdultChildChild, PreschoolDouble-Blind MethodFemaleFollow-Up StudiesHumansImmunosuppressive AgentsMaleProspective StudiesRecurrenceRetrospective StudiesImmunologic FactorsImmunosuppressive AgentsRituximabComplicated nephrotic syndromeFrequently relapsing nephrotic syndromeImmunosuppressive agentsRituximabSteroid-dependent nephrotic syndrome

Identifiers

PMID28664242
OpenAlexW2731755024

What OpenQuestion holds

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Registered trials

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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.